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TABLE OF CONTENTS
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One) | ||
ý |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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For the Quarterly Period Ended September 30, 2011 |
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or |
||
o |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
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For the transition period from to |
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Commission file number 1-15525 |
EDWARDS LIFESCIENCES CORPORATION
(Exact name of registrant as specified in its charter)
Delaware | 36-4316614 | |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) | |
One Edwards Way, Irvine, California |
92614 |
|
(Address of principal executive offices) | (Zip Code) | |
(949) 250-2500 (Registrant's telephone number, including area code) |
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ý No o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes ý No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of "large accelerated filer," "accelerated filer," and "smaller reporting company" in Rule 12b-2 of the Exchange Act.
Large accelerated filer ý | Accelerated filer o | Non-accelerated filer o (Do not check if a smaller reporting company) |
Smaller Reporting Company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No ý
The number of shares outstanding of the registrant's common stock, $1.00 par value, as of October 31, 2011 was 114,075,181.
EDWARDS LIFESCIENCES CORPORATION
FORM 10-Q
For the quarterly period ended September 30, 2011
EDWARDS LIFESCIENCES CORPORATION
CONSOLIDATED CONDENSED BALANCE SHEETS
(in millions, except par value; unaudited)
|
September 30, 2011 |
December 31, 2010 |
|||||||
---|---|---|---|---|---|---|---|---|---|
ASSETS |
|||||||||
Current assets |
|||||||||
Cash and cash equivalents |
$ | 451.1 | $ | 396.1 | |||||
Accounts and other receivables, net of allowances of $17.4 and $11.6, respectively |
346.8 | 302.5 | |||||||
Inventories, net (Note 3) |
247.9 | 203.6 | |||||||
Deferred income taxes |
25.3 | 32.3 | |||||||
Prepaid expenses |
43.0 | 35.4 | |||||||
Other current assets |
67.8 | 62.7 | |||||||
Total current assets |
1,181.9 | 1,032.6 | |||||||
Property, plant and equipment, net |
286.4 | 269.8 | |||||||
Goodwill (Note 4) |
349.8 | 315.2 | |||||||
Other intangible assets, net (Note 5) |
70.2 | 67.1 | |||||||
Investments in unconsolidated affiliates (Note 6) |
21.4 | 25.0 | |||||||
Deferred income taxes |
48.6 | 44.5 | |||||||
Other assets |
24.6 | 13.0 | |||||||
|
$ | 1,982.9 | $ | 1,767.2 | |||||
LIABILITIES AND STOCKHOLDERS' EQUITY |
|||||||||
Current liabilities |
|||||||||
Accounts payable and accrued liabilities |
$ | 302.0 | $ | 296.0 | |||||
Short-term debt |
| 41.8 | |||||||
Total current liabilities |
302.0 | 337.8 | |||||||
Long-term debt (Note 7) |
175.0 | | |||||||
Other long-term liabilities |
151.3 | 121.2 | |||||||
Commitments and contingencies (Note 12) |
|||||||||
Stockholders' equity |
|||||||||
Preferred stock, $.01 par value, authorized 50.0 shares, no shares outstanding |
| | |||||||
Common stock, $1.00 par value, 350.0 shares authorized, 119.5 and 117.0 shares issued, and 114.2 and 115.0 shares outstanding, respectively |
119.5 | 117.0 | |||||||
Additional paid-in capital |
326.5 | 211.3 | |||||||
Retained earnings |
1,297.6 | 1,124.0 | |||||||
Accumulated other comprehensive loss |
(23.2 | ) | (42.1 | ) | |||||
Treasury stock, at cost, 5.3 and 2.0 shares, respectively |
(365.8 | ) | (102.0 | ) | |||||
Total stockholders' equity |
1,354.6 | 1,308.2 | |||||||
|
$ | 1,982.9 | $ | 1,767.2 | |||||
The accompanying notes are an integral part of these
consolidated condensed financial statements.
1
EDWARDS LIFESCIENCES CORPORATION
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS
(in millions, except per share information; unaudited)
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2011 | 2010 | 2011 | 2010 | |||||||||||
Net sales |
$ | 412.7 | $ | 348.9 | $ | 1,248.4 | $ | 1,054.6 | |||||||
Cost of goods sold |
125.6 | 95.8 | 370.2 | 294.8 | |||||||||||
Gross profit |
287.1 | 253.1 | 878.2 | 759.8 | |||||||||||
Selling, general and administrative expenses |
165.5 | 133.0 | 479.0 | 407.6 | |||||||||||
Research and development expenses |
61.7 | 52.7 | 185.6 | 148.5 | |||||||||||
Special charges, net (Note 2) |
| 3.9 | 4.0 | 12.2 | |||||||||||
Interest expense (income), net |
| 0.4 | (0.3 | ) | 1.1 | ||||||||||
Other expense (income), net |
2.3 | (3.1 | ) | (5.1 | ) | (7.7 | ) | ||||||||
Income before provision for income taxes |
57.6 | 66.2 | 215.0 | 198.1 | |||||||||||
Provision for income taxes |
6.0 | 18.2 | 41.4 | 44.9 | |||||||||||
Net income |
$ | 51.6 | $ | 48.0 | $ | 173.6 | $ | 153.2 | |||||||
Share information (Note 14) |
|||||||||||||||
Earnings per share: |
|||||||||||||||
Basic |
$ | 0.45 | $ | 0.42 | $ | 1.51 | $ | 1.35 | |||||||
Diluted |
$ | 0.43 | $ | 0.40 | $ | 1.45 | $ | 1.29 | |||||||
Weighted-average number of common shares outstanding: |
|||||||||||||||
Basic |
114.6 | 113.6 | 114.8 | 113.4 | |||||||||||
Diluted |
119.0 | 118.9 | 119.8 | 118.9 |
The accompanying notes are an integral part of these
consolidated condensed financial statements.
2
EDWARDS LIFESCIENCES CORPORATION
CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS
(in millions; unaudited)
|
Nine Months Ended September 30, |
|||||||||
---|---|---|---|---|---|---|---|---|---|---|
|
2011 | 2010 | ||||||||
Cash flows from operating activities |
||||||||||
Net income |
$ | 173.6 | $ | 153.2 | ||||||
Adjustments to reconcile net income to cash provided by operating activities: |
||||||||||
Depreciation and amortization |
43.2 | 41.1 | ||||||||
Stock-based compensation (Note 11) |
26.0 | 22.4 | ||||||||
Excess tax benefit from stock plans |
(47.0 | ) | (42.0 | ) | ||||||
Deferred income taxes |
2.2 | (6.8 | ) | |||||||
Special charges, net (Note 2) |
4.0 | 12.2 | ||||||||
Other |
(1.2 | ) | (5.3 | ) | ||||||
Changes in operating assets and liabilities: |
||||||||||
Accounts and other receivables, net |
(38.5 | ) | (31.8 | ) | ||||||
Inventories, net |
(38.3 | ) | (43.5 | ) | ||||||
Accounts payable and accrued liabilities |
43.0 | 65.2 | ||||||||
Prepaid expenses and other current assets |
9.3 | (11.7 | ) | |||||||
Other |
(4.9 | ) | 4.4 | |||||||
Net cash provided by operating activities |
171.4 | 157.4 | ||||||||
Cash flows from investing activities |
||||||||||
Capital expenditures |
(50.6 | ) | (40.1 | ) | ||||||
Acquisition (Note 4) |
(42.6 | ) | | |||||||
Proceeds from (investments in) unconsolidated affiliates, net |
6.9 | (1.9 | ) | |||||||
Proceeds from sale of assets |
3.9 | 5.1 | ||||||||
Proceeds from (investments in) trading securities, net |
3.3 | (0.3 | ) | |||||||
Investments in intangible assets |
(2.3 | ) | (1.2 | ) | ||||||
Net cash used in investing activities |
(81.4 | ) | (38.4 | ) | ||||||
Cash flows from financing activities |
||||||||||
Proceeds from issuance of debt |
505.5 | 216.8 | ||||||||
Payments on debt |
(376.7 | ) | (207.6 | ) | ||||||
Purchases of treasury stock |
(263.3 | ) | (200.0 | ) | ||||||
Proceeds from stock plans |
48.6 | 73.8 | ||||||||
Excess tax benefit from stock plans |
47.0 | 42.0 | ||||||||
Other |
0.7 | (2.3 | ) | |||||||
Net cash used in financing activities |
(38.2 | ) | (77.3 | ) | ||||||
Effect of currency exchange rate changes on cash and cash equivalents |
3.2 | (14.8 | ) | |||||||
Net increase in cash and cash equivalents |
55.0 | 26.9 | ||||||||
Cash and cash equivalents at beginning of period |
396.1 | 334.1 | ||||||||
Cash and cash equivalents at end of period |
$ | 451.1 | $ | 361.0 | ||||||
Supplemental disclosures: |
||||||||||
Non-cash investing and financing transactions: |
||||||||||
Distribution of treasury shares to effect stock split |
| $ | 970.3 |
The accompanying notes are an integral part of these
consolidated condensed financial statements.
3
The accompanying interim consolidated condensed financial statements and related disclosures have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC") and should be read in conjunction with the consolidated financial statements and notes included in Edwards Lifesciences Corporation's Annual Report on Form 10-K for the year ended December 31, 2010. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles ("GAAP") have been condensed or omitted.
In the opinion of management of Edwards Lifesciences Corporation ("Edwards Lifesciences" or the "Company"), the interim consolidated condensed financial statements reflect all adjustments considered necessary for a fair statement of the interim periods. All such adjustments are of a normal, recurring nature. The results of operations for the interim periods are not necessarily indicative of the results of operations to be expected for the full year. Certain reclassifications of previously reported amounts have been made to conform to classifications used in the current year.
Recently Adopted Accounting Standards
In October 2009, the Financial Accounting Standards Board ("FASB") issued an amendment to the accounting guidance on revenue recognition to require companies to allocate revenue in arrangements involving multiple deliverables based on estimated selling price in the absence of vendor-specific objective evidence or third-party evidence of selling price for the deliverables. The guidance was also amended to eliminate the requirement that all undelivered elements must have objective and reliable evidence of fair value before a company can recognize the portion of the overall arrangement fee that is attributable to items that have already been delivered. The guidance was effective for revenue arrangements entered into or materially modified in fiscal years beginning on or after June 15, 2010. The adoption of this guidance did not have a material impact on the Company's consolidated financial statements.
In April 2010, the FASB issued an amendment to the accounting guidance on revenue recognition to provide guidance on defining a milestone and determining when it may be appropriate to apply the milestone method of revenue recognition for research and development transactions. Consideration that is contingent upon achievement of a milestone in its entirety may be recognized as revenue in the period in which the milestone is achieved only if the milestone meets all criteria to be considered substantive. The guidance was effective for milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010. The adoption of this guidance did not have an impact on the Company's consolidated financial statements.
In December 2010, the FASB issued an amendment to the accounting guidance on business combinations to clarify the acquisition date that should be used for reporting pro forma financial information disclosures when comparative financial statements are presented. An entity is required to disclose pro forma revenue and earnings of the combined entity as though the business combination that occurred during the current year had occurred as of the beginning of the comparable prior annual reporting period only. The guidance also expands the supplemental pro forma disclosures to include a description of the nature and amount of material, nonrecurring pro forma adjustments directly attributable to the business combination included in the reported pro forma revenue and earnings. The guidance was effective prospectively for business combinations for which the acquisition date is on or after the beginning of the first annual reporting period beginning on or after December 15, 2010. The adoption of this guidance did not have an impact on the Company's consolidated financial statements.
4
New Accounting Standards Not Yet Adopted
In May 2011, the FASB issued an amendment to the accounting guidance on fair value measurements to ensure that United States GAAP and International Financial Reporting Standards have common requirements for fair value measurement and disclosures, including a consistent definition of fair value. The guidance is effective for interim and annual periods beginning on or after December 15, 2011. The Company does not expect the adoption of this guidance will have a material impact on its consolidated financial statements.
In June 2011, the FASB issued an amendment to the accounting guidance on the presentation of comprehensive income. The guidance eliminates the option to present components of other comprehensive income as part of the statement of changes in stockholders' equity, and instead requires that all nonowner changes in stockholders' equity be presented in either a single continuous statement of comprehensive income or in two separate but consecutive statements. The guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2011, with early adoption permitted.
In September 2011, the FASB issued an amendment to the accounting guidance on goodwill to permit an entity to first assess qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount as a basis for determining whether it is necessary to perform the two-step goodwill impairment test. The guidance is effective for annual and interim goodwill impairment tests performed for fiscal years beginning after December 15, 2011, with early adoption permitted. The Company does not expect the adoption of this guidance will have a material impact on its consolidated financial statements.
2. SPECIAL CHARGES, NET
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2011 | 2010 | 2011 | 2010 | ||||||||||
|
(in millions) |
|||||||||||||
Greece receivables reserve |
$ | | $ | | $ | 4.0 | $ | | ||||||
Investment impairment |
| 3.9 | | 3.9 | ||||||||||
MONARC program discontinuation |
| | | 8.3 | ||||||||||
Special charges, net |
$ | | $ | 3.9 | $ | 4.0 | $ | 12.2 | ||||||
Greece Receivables Reserve
In June 2011, the Company recorded a $4.0 million charge to reflect the increased collection risk associated with its receivables in Greece.
Realignment Expenses, net
In December 2010, the Company recorded a $7.2 million charge related primarily to severance expenses associated with a global workforce realignment impacting 84 employees. As of September 30, 2011, the Company's remaining severance obligations of $1.5 million are expected to be substantially paid by March 2012.
Investment Impairment
In September 2010, the Company recorded a $3.9 million charge related to the other-than-temporary impairment of two non-strategic investments in unconsolidated affiliates. The
5
Company concluded that the impairment of these investments was other-than-temporary based upon the continuing duration and severity of the impairment.
MONARC Program Discontinuation
During the second quarter of 2010, the Company decided to discontinue its MONARC transcatheter mitral valve program due to slow enrollment in the EVOLUTION II trial. As a result, the Company recorded an $8.3 million charge consisting of a $7.6 million impairment of intangible assets associated with the program and $0.7 million of clinical trial costs that will continue to be incurred under a contractual obligation that existed prior to the discontinuation date.
3. INVENTORIES, NET
Inventories, net of reserves, consisted of the following (in millions):
|
September 30, 2011 |
December 31, 2010 |
|||||
---|---|---|---|---|---|---|---|
Raw materials |
$ | 47.6 | $ | 38.2 | |||
Work in process |
70.3 | 39.0 | |||||
Finished products |
130.0 | 126.4 | |||||
|
$ | 247.9 | $ | 203.6 | |||
4. ACQUISITION
On March 11, 2011, the Company acquired all the outstanding shares of Embrella Cardiovascular, Inc. ("Embrella"), including shares already owned by the Company, for an aggregate cash purchase price of $42.6 million. In connection with the acquisition, the Company placed $4.5 million of the purchase price into escrow to satisfy any claims for indemnification made in accordance with the terms of the merger agreement. Any remaining funds will be disbursed to Embrella's former shareholders one year after the acquisition date. As of September 30, 2011, no claims for indemnification had been made. Acquisition-related costs of $0.9 million were recorded in "Other Expense (Income), net" during the quarter ended March 31, 2011.
Embrella is a start-up medical device company developing a device for cerebral embolic protection during cardiovascular procedures. The acquisition provides the Company with full rights to develop and commercialize Embrella's embolic deflector system, designed to be used as a protective shield during transcatheter heart valve procedures. The acquisition was accounted for as a business combination. Tangible and intangible assets acquired were recorded based on their estimated fair values at the acquisition date. The excess of the purchase price over the fair value of net assets acquired was allocated to goodwill. The following table summarizes the fair value of the assets acquired (in millions):
Goodwill |
$ | 34.6 | ||
In-process research and development ("IPR&D") |
6.3 | |||
Unpatented technology |
5.8 | |||
Deferred income taxes |
(4.1 | ) | ||
|
$ | 42.6 | ||
Goodwill includes expected synergies and other benefits the Company believes will result from the acquisition. Goodwill was assigned to the Europe segment and is partially deductible for tax purposes. IPR&D has been capitalized at fair value as an intangible asset with an indefinite life and will be assessed for impairment in subsequent periods. The fair value of the IPR&D was determined using the income approach. This approach determines fair value based on cash flow projections which are
6
discounted to present value using a risk-adjusted rate of return. Upon completion of development, the underlying research and development intangible asset will be amortized over its estimated useful life. Developed technology assets are being amortized over a weighted-average useful life of 8 years.
Prior to the acquisition date, the Company owned approximately 9% of the fully-diluted outstanding shares of Embrella. As a result of the acquisition, the Company remeasured its previously held ownership in Embrella, which had a carrying value of $1.3 million at the date of acquisition, at fair value and, accordingly, recognized a gain of $3.1 million. The gain was recorded in "Other Expense (Income), net" during the quarter ended March 31, 2011, and the cash received was recorded in "Proceeds from (Investments in) Unconsolidated Affiliates, net" on the consolidated condensed statements of cash flows. The fair value of the Company's previous ownership interest in Embrella was determined using a market approach considering the amounts paid to acquire the remaining outstanding shares of Embrella.
The results of operations for Embrella have been included in the accompanying consolidated condensed financial statements from the date of acquisition. Pro forma results have not been presented as the results of Embrella are not material in relation to the consolidated financial statements of the Company.
5. OTHER INTANGIBLE ASSETS
Other intangible assets consisted of the following (in millions):
|
September 30, 2011 | December 31, 2010 | ||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Cost | Accumulated Amortization |
Net Carrying Value |
Cost | Accumulated Amortization |
Net Carrying Value |
||||||||||||||
Amortizable intangible assets |
||||||||||||||||||||
Patents |
$ | 205.5 | $ | (156.0 | ) | $ | 49.5 | $ | 203.0 | $ | (147.8 | ) | $ | 55.2 | ||||||
Unpatented technology |
40.0 | (31.1 | ) | 8.9 | 35.0 | (29.6 | ) | 5.4 | ||||||||||||
Other |
12.2 | (6.7 | ) | 5.5 | 12.4 | (5.9 | ) | 6.5 | ||||||||||||
|
257.7 | (193.8 | ) | 63.9 | 250.4 | (183.3 | ) | 67.1 | ||||||||||||
Unamortizable intangible assets |
||||||||||||||||||||
IPR&D |
6.3 | | 6.3 | | | | ||||||||||||||
|
$ | 264.0 | $ | (193.8 | ) | $ | 70.2 | $ | 250.4 | $ | (183.3 | ) | $ | 67.1 | ||||||
In March 2011, the Company completed its acquisition of Embrella (see Note 4). This transaction resulted in a net increase to unpatented technology of $5.8 million and IPR&D of $6.3 million.
The net carrying value of patents includes $16.2 million of capitalized legal costs related to the defense and enforcement of issued patents and trademarks for which success is deemed probable as of September 30, 2011.
Amortization expense related to other intangible assets was $2.4 million and $4.2 million for the three months ended September 30, 2011 and 2010, respectively, and $10.8 million and $12.4 million for
7
the nine months ended September 30, 2011 and 2010, respectively. Estimated amortization expense for each of the years ending December 31 is as follows (in millions):
2011 |
$ | 13.0 | ||
2012 |
12.1 | |||
2013 |
12.0 | |||
2014 |
10.8 | |||
2015 |
9.6 |
The Company expenses costs incurred to renew or extend the term of acquired intangible assets. In September 2011, the Company extended the estimated benefit period of one of its patents through February 2017.
6. INVESTMENTS IN UNCONSOLIDATED AFFILIATES
The Company has a number of equity investments in privately and publicly held companies. Investments in these unconsolidated affiliates are as follows:
|
September 30, 2011 |
December 31, 2010 |
|||||||
---|---|---|---|---|---|---|---|---|---|
|
(in millions) |
||||||||
Available-for-sale investments |
|||||||||
Cost |
$ | 2.0 | $ | 4.1 | |||||
Unrealized gains |
0.9 | 3.6 | |||||||
Fair value of available-for-sale investments |
2.9 | 7.7 | |||||||
Equity method investments |
|||||||||
Cost |
12.4 | 11.5 | |||||||
Equity in losses |
(0.5 | ) | (1.5 | ) | |||||
Carrying value of equity method investments |
11.9 | 10.0 | |||||||
Cost method investments |
|||||||||
Carrying value of cost method investments |
6.6 | 7.3 | |||||||
Total investments in unconsolidated affiliates |
$ | 21.4 | $ | 25.0 | |||||
Proceeds from sales of available-for-sale investments were $3.6 million for the three and nine months ended September 30, 2011, and $0.3 million for the three and nine months ended September 30, 2010. The Company realized pre-tax gains from these sales of $1.4 million for the three and nine months ended September 30, 2011, and $0.2 million for the three and nine months ended September 30, 2010. In March 2011, the Company acquired all of the outstanding shares of Embrella, which was accounted for as a cost method investment prior to the acquisition. As a result, the Company has consolidated Embrella as of the acquisition date. See Note 4 for additional information.
7. DEBT
In July 2011, Edwards Lifesciences entered into a Four-Year Credit Agreement ("the Credit Facility") which matures on July 29, 2015. The proceeds of the Credit Facility were used to refinance the Company's previous Five-Year Unsecured Revolving Credit Agreement. The Credit Facility provides up to an aggregate of $500.0 million in borrowings in multiple currencies. Borrowings generally bear interest at the London interbank offering rate ("LIBOR") plus 0.875%, subject to adjustment for leverage ratio changes as defined in the Credit Facility. The Company also pays a facility fee of 0.125% on the entire $500.0 million facility whether or not drawn. The facility fee is also subject to adjustment for leverage ratio changes. All amounts outstanding under the Credit Facility
8
have been classified as long-term obligations as these borrowings are expected to be refinanced pursuant to the Credit Facility. Issuance costs of $1.8 million are being amortized to interest expense over 4 years. As of September 30, 2011, borrowings of $175.0 million were outstanding under the Credit Facility. The Credit Facility is unsecured and contains various financial and other covenants, including a maximum leverage ratio and a minimum interest coverage ratio, as defined in the Credit Facility. The Company was in compliance with all covenants at September 30, 2011.
8. FAIR VALUE MEASUREMENTS AND FINANCIAL INSTRUMENTS
The consolidated condensed financial statements include financial instruments for which the fair market value of such instruments may differ from amounts reflected on a historical cost basis. Financial instruments of the Company consist of cash deposits, accounts and other receivables, investments in unconsolidated affiliates, accounts payable, certain accrued liabilities and borrowings under a revolving credit agreement. The carrying value of these financial instruments generally approximates fair value due to their short-term nature.
Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. The Company prioritizes the inputs used to determine fair values in one of the following three categories:
Level 1Quoted
market prices in active markets for identical assets or liabilities.
Level 2Inputs, other than quoted prices in active markets, that are observable, either directly or indirectly.
Level 3Unobservable inputs that are not corroborated by market data.
In certain cases, the inputs used to measure fair value may fall into different levels of the fair value hierarchy. In such cases, the level in the fair value hierarchy within which the fair value measurement in its entirety falls has been determined based on the lowest level input that is significant to the fair value measurement in its entirety.
9
Assets and Liabilities Measured at Fair Value on a Recurring Basis
The following table summarizes the Company's financial instruments which are measured at fair value on a recurring basis (in millions):
September 30, 2011
|
Level 1 | Level 2 | Level 3 | Total | ||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Assets |
||||||||||||||
Investments held for executive deferred compensation plan |
$ | 10.8 | $ | | $ | | $ | 10.8 | ||||||
Investments in unconsolidated affiliates |
2.9 | | | 2.9 | ||||||||||
Derivatives |
| 1.6 | | 1.6 | ||||||||||
|
$ | 13.7 | $ | 1.6 | $ | | $ | 15.3 | ||||||
Liabilities |
||||||||||||||
Executive deferred compensation plan |
$ | 8.6 | $ | | $ | | $ | 8.6 | ||||||
December 31, 2010 |
||||||||||||||
Assets |
||||||||||||||
Investments held for executive deferred compensation plan |
$ | 18.3 | $ | | $ | | $ | 18.3 | ||||||
Investments in unconsolidated affiliates |
7.7 | | | 7.7 | ||||||||||
|
$ | 26.0 | $ | | $ | | $ | 26.0 | ||||||
Liabilities |
||||||||||||||
Derivatives |
$ | | $ | 14.7 | $ | | $ | 14.7 | ||||||
Executive deferred compensation plan |
13.1 | | | 13.1 | ||||||||||
|
$ | 13.1 | $ | 14.7 | $ | | $ | 27.8 | ||||||
Executive Deferred Compensation Plan
The Company holds investments in trading securities related to its executive deferred compensation plan ("EDCP"). The amounts deferred under the EDCP are invested in a variety of stock and bond mutual funds. The fair values of these investments and the corresponding liabilities are based on quoted market prices and are categorized as Level 1.
Investments in Unconsolidated Affiliates
Investments in unconsolidated affiliates are long-term equity investments in companies that are in various stages of development. Certain of the Company's investments in unconsolidated affiliates are designated as available-for-sale. These investments are carried at fair market value based on quoted market prices and are categorized as Level 1.
Derivative Instruments
The Company uses derivative financial instruments in the form of foreign currency forward exchange contracts and foreign currency option contracts to manage foreign currency exposures. All derivatives contracts are recognized on the balance sheet at their fair value. The fair value for derivatives is determined based on quoted spot and foreign currency exchange rates discounted to present as appropriate. The fair value of options also takes into account forward implied volatility. The valuation procedures are based upon well recognized financial principles. Although readily observable data is used in the valuations, different valuation methods could have an effect on the estimated fair value. The derivative instruments are categorized as Level 2.
10
Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis
The Company has assets that are subject to measurement at fair value on a non-recurring basis, including assets acquired in a business combination, such as goodwill and intangible assets, and other long-lived assets. The Company reviews the carrying value of intangible and other long-lived assets whenever events and circumstances indicate that the carrying amounts of the assets may not be recoverable. If it is determined that the assets are impaired, the carrying value would be reduced to estimated fair market value. During the nine months ended September 30, 2011, the Company had no impairments related to assets subject to measurement at fair value on a non-recurring basis. In March 2011, the Company acquired Embrella. This transaction resulted in an increase to "Goodwill" and "Other Intangible Assets, net" of $34.6 million and $12.1 million, respectively. See Note 4 for additional information. During the nine months ended September 30, 2010, the Company recorded a $7.6 million impairment of intangible assets related to the Company's MONARC transcatheter mitral valve program, which was discontinued due to slow enrollment in the EVOLUTION II trial (see Note 2).
9. DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES
The Company uses derivative financial instruments to manage its currency exchange rate risk as summarized below. Notional amounts are stated in United States dollar equivalents at spot exchange rates at the respective dates.
|
September 30, 2011 | December 31, 2010 | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Notional Amount |
Fair Value Asset (Liability) |
Notional Amount |
Fair Value Asset (Liability) |
|||||||||
|
(in millions) |
||||||||||||
Foreign currency forward exchange contracts |
$ | 781.5 | $ | 1.6 | $ | 486.0 | $ | (12.5 | ) | ||||
Foreign currency option contracts |
| | 53.2 | (2.2 | ) |
The Company uses foreign currency forward exchange contracts and foreign currency option contracts to offset the changes due to currency rate movements in the amount of future cash flows associated with intercompany transactions expected to occur within the next thirteen months. These foreign currency forward exchange contracts and foreign currency option contracts are designated as cash flow hedges. Certain of the Company's locations have assets and liabilities denominated in currencies other than their functional currencies resulting from intercompany and third-party transactions. The Company uses foreign currency forward exchange contracts that are not designated as hedging instruments to offset the transaction gains and losses associated with certain of these assets and liabilities. All foreign currency forward exchange contracts and foreign currency option contracts are denominated in currencies of major industrial countries, principally the Euro and the Japanese yen. It is the Company's policy not to enter into derivative financial instruments for speculative purposes.
All derivative financial instruments are recognized at fair value in the consolidated condensed balance sheets. The Company reports in "Other Comprehensive Income" ("OCI") the effective portion of the gain or loss on derivative financial instruments that are designated and that qualify as cash flow hedges. The Company reclassifies these gains and losses into earnings in the same period in which the underlying hedged transactions affect earnings. Any hedge ineffectiveness (which represents the amount by which the changes in the fair value of the derivative exceed the variability in the cash flows of the forecasted transaction) is recorded in current period earnings. The gains and losses on derivative financial instruments for which the Company does not elect hedge accounting treatment are recognized in the consolidated condensed statements of operations in each period, based upon the change in the fair value of the derivative financial instrument. Cash flows from derivative financial instruments are reported as operating activities in the consolidated condensed statements of cash flows.
11
Derivative financial instruments involve credit risk in the event the counterparty should default. It is the Company's policy to execute such instruments with global financial institutions that the Company believes to be creditworthy. The Company diversifies its derivative financial instruments among counterparties to minimize exposure to any one of these entities.
The following table presents the location and fair value amounts of derivative instruments reported in the consolidated condensed balance sheets (in millions):
|
|
Fair Value | ||||||||
---|---|---|---|---|---|---|---|---|---|---|
Derivatives designated as hedging instruments
|
Balance Sheet Location |
September 30, 2011 |
December 31, 2010 |
|||||||
Assets |
||||||||||
Foreign currency contracts |
Prepaid expenses | $ | 1.6 | $ | | |||||
Liabilities |
||||||||||
Foreign currency contracts |
Accrued liabilities | $ | | $ | 14.7 |
The following tables present the effect of derivative instruments on the consolidated condensed statements of operations (in millions):
|
Amount of Gain or (Loss) Recognized in OCI on Derivative (Effective Portion) |
|
Amount of Gain or (Loss) Reclassified from Accumulated OCI into Income |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Three Months Ended September 30, |
|
Three Months Ended September 30, |
||||||||||||
|
Location of Gain or (Loss) Reclassified from Accumulated OCI into Income |
||||||||||||||
Derivatives in cash flow hedging relationships
|
2011 | 2010 | 2011 | 2010 | |||||||||||
Foreign currency contracts |
$ | 17.3 | $ | (24.9 | ) | Cost of goods sold | $ | (11.6 | ) | $ | 4.0 |
|
Amount of Gain or (Loss) Recognized in OCI on Derivative (Effective Portion) |
|
Amount of Gain or (Loss) Reclassified from Accumulated OCI into Income |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Nine Months Ended September 30, |
|
Nine Months Ended September 30, |
||||||||||||
|
Location of Gain or (Loss) Reclassified from Accumulated OCI into Income |
||||||||||||||
Derivatives in cash flow hedging relationships
|
2011 | 2010 | 2011 | 2010 | |||||||||||
Foreign currency contracts |
$ | (9.5 | ) | $ | (7.1 | ) | Cost of goods sold | $ | (21.5 | ) | $ | (1.0 | ) |
|
|
Amount of Gain or (Loss) Recognized in Income on Derivative |
|||||||
---|---|---|---|---|---|---|---|---|---|
|
|
Three Months Ended September 30, |
|||||||
|
Location of Gain or (Loss) Recognized in Income on Derivative |
||||||||
Derivatives not designated as hedging instruments
|
2011 | 2010 | |||||||
Foreign currency contracts |
Other expense (income), net | $ | (1.9 | ) | $ | (3.0 | ) |
|
|
Amount of Gain or (Loss) Recognized in Income on Derivative |
|||||||
---|---|---|---|---|---|---|---|---|---|
|
|
Nine Months Ended September 30, |
|||||||
|
Location of Gain or (Loss) Recognized in Income on Derivative |
||||||||
Derivatives not designated as hedging instruments
|
2011 | 2010 | |||||||
Foreign currency contracts |
Other expense (income), net | $ | (6.2 | ) | $ | (4.4 | ) |
The Company expects that during the next twelve months it will reclassify to earnings a $7.5 million loss currently recorded in "Accumulated Other Comprehensive Loss." For the nine months
12
ended September 30, 2011 and 2010, the Company did not record any gains or losses due to hedge ineffectiveness.
10. DEFINED BENEFIT PLANS
The components of net periodic benefit costs for the three and nine months ended September 30, 2011 and 2010 were as follows (in millions):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2011 | 2010 | 2011 | 2010 | ||||||||||
Service cost |
$ | 1.5 | $ | 1.2 | $ | 4.6 | $ | 3.5 | ||||||
Employee contributions |
| | | | ||||||||||
Interest cost |
0.5 | 0.5 | 1.5 | 1.4 | ||||||||||
Expected return on plan assets |
(0.3 | ) | (0.3 | ) | (1.0 | ) | (0.9 | ) | ||||||
Amortization of actuarial loss, prior service credit and other |
0.1 | | 0.3 | 0.1 | ||||||||||
Net periodic pension benefit cost |
$ | 1.8 | $ | 1.4 | $ | 5.4 | $ | 4.1 | ||||||
11. STOCK-BASED COMPENSATION
Stock-based compensation expense related to awards issued under the Company's incentive compensation plans for the three and nine months ended September 30, 2011 and 2010 was as follows (in millions):
|
Three Months Ended September 30 |
Nine Months Ended September 30, |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2011 | 2010 | 2011 | 2010 | ||||||||||
Cost of goods sold |
$ | 1.3 | $ | 0.9 | $ | 3.0 | $ | 2.1 | ||||||
Selling, general and administrative expenses |
7.5 | 6.4 | 18.7 | 16.8 | ||||||||||
Research and development expenses |
1.7 | 1.3 | 4.3 | 3.5 | ||||||||||
Total stock-based compensation expense |
$ | 10.5 | $ | 8.6 | $ | 26.0 | $ | 22.4 | ||||||
At September 30, 2011, the total remaining compensation cost related to nonvested stock options, restricted stock units and employee stock purchase subscription awards amounted to $61.7 million, which will be amortized on a straight-line basis over the weighted-average remaining requisite service period of 31 months.
During the nine months ended September 30, 2011, the Company granted 1.1 million stock options at a weighted-average exercise price of $88.80 and 0.2 million shares of restricted stock units at a weighted-average grant-date fair value of $87.83.
13
Fair Value Disclosures
The Black-Scholes option pricing model was used with the following weighted-average assumptions for options granted during the following periods:
Option Awards
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2011 | 2010 | 2011 | 2010 | |||||||||
Risk-free interest rate |
1.4 | % | 1.7 | % | 1.7 | % | 2.0 | % | |||||
Expected dividend yield |
None | None | None | None | |||||||||
Expected volatility |
27.2 | % | 25.7 | % | 27.3 | % | 25.9 | % | |||||
Expected term (years) |
4.7 | 4.8 | 4.5 | 4.6 | |||||||||
Fair value, per share |
$ | 21.72 | $ | 14.25 | $ | 22.81 | $ | 12.98 |
The Black-Scholes option pricing model was used with the following weighted-average assumptions for employee stock purchase plan ("ESPP") subscriptions granted during the following periods:
ESPP
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2011 | 2010 | 2011 | 2010 | |||||||||
Risk-free interest rate |
0.1 | % | 0.3 | % | 0.2 | % | 0.3 | % | |||||
Expected dividend yield |
None | None | None | None | |||||||||
Expected volatility |
29.8 | % | 24.0 | % | 27.6 | % | 27.5 | % | |||||
Expected term (years) |
0.6 | 0.6 | 0.6 | 0.6 | |||||||||
Fair value, per share |
$ | 21.06 | $ | 12.61 | $ | 20.02 | $ | 12.09 |
12. COMMITMENTS AND CONTINGENCIES
In February 2008, Edwards Lifesciences filed a lawsuit against CoreValve, Inc. ("CoreValve") in the United States District Court for the District of Delaware alleging that its ReValving System infringes three of the Company's U.S. Andersen patents, later narrowed to one patent ("the '552 patent"). CoreValve was acquired by Medtronic, Inc. ("Medtronic") in April 2009. In April 2010, a federal jury found that patent to be valid and found that CoreValve willfully infringes it. The jury also awarded Edwards $73.9 million in damages. In February 2011, the District Court reaffirmed the jury decision and ruled that Edwards is entitled to recover additional damages due to CoreValve's continued infringing sales from the trial through the life of the patent, plus interest. In the same ruling, the court denied Edwards' motions for a permanent injunction, as well as its motion for increased damages relating to CoreValve's willful infringement. Both Edwards and CoreValve have appealed. A second lawsuit is pending in the same court against CoreValve and Medtronic alleging infringement of three U.S. Andersen patents. In September 2010, the United States Patent and Trademark Office granted Medtronic's third request to reexamine the validity of the claim of the '552 patent and in July 2011 confirmed the validity of that patent.
In June 2011, Medtronic filed a lawsuit in the United States District Court for the District of Minnesota alleging that certain surgical valve holders and a surgical embolic filter device infringe its patents. Medtronic also filed another lawsuit in the United States District Court for the Central District of California alleging that the Edwards SAPIEN transcatheter heart valve infringes a Medtronic patent.
14
In the California action, Edwards has counterclaimed against Medtronic, alleging that the Medtronic CoreValve heart valve infringes Edwards' U.S. Letac-Cribier transcatheter heart valve patent.
In March and September 2010, the Company received grand jury subpoenas for documents from the United States Attorney's Office in the Central District of California in connection with an investigation by the Food and Drug Administration. The subpoenas to the Company seek records relating to the Vigilance I Monitor model with software release 5.3 that was the subject of a voluntary field recall by the Company in June 2006. The Company is cooperating fully with the investigation.
In addition, Edwards Lifesciences is or may be a party to, or may otherwise be responsible for, pending or threatened lawsuits related primarily to products and services currently or formerly manufactured or performed, as applicable, by Edwards Lifesciences. Such cases and claims raise difficult and complex factual and legal issues and are subject to many uncertainties, including, but not limited to, the facts and circumstances of each particular case or claim, the jurisdiction in which each suit is brought, and differences in applicable law. Upon resolution of any such legal matter or other claim, Edwards Lifesciences may incur charges in excess of established reserves. The Company is not able to estimate the amount or range of any loss for legal contingencies for which there is no reserve or additional loss for matters already reserved. While any such charge could have a material adverse impact on Edwards Lifesciences' net income or cash flows in the period in which it is recorded or paid, management does not believe that any such charge relating to any currently pending lawsuit would have a material adverse effect on Edwards Lifesciences' financial position, results of operations or liquidity.
Edwards Lifesciences is subject to various environmental laws and regulations both within and outside of the United States. The operations of Edwards Lifesciences, like those of other medical device companies, involve the use of substances regulated under environmental laws, primarily in manufacturing and sterilization processes. While it is difficult to quantify the potential impact of continuing compliance with environmental protection laws, management believes that such compliance will not have a material impact on Edwards Lifesciences' financial position, results of operations or liquidity.
13. COMPREHENSIVE INCOME
Reconciliation of net income to comprehensive income is as follows (in millions):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2011 | 2010 | 2011 | 2010 | ||||||||||
Net income |
$ | 51.6 | $ | 48.0 | $ | 173.6 | $ | 153.2 | ||||||
Other comprehensive income: |
||||||||||||||
Currency translation adjustments |
(29.8 | ) | 42.7 | 13.3 | (13.6 | ) | ||||||||
Unrealized net loss on investments in unconsolidated affiliates, net of tax |
(0.4 | ) | (0.1 | ) | (0.7 | ) | (2.7 | ) | ||||||
Reclassification of net realized investment (gain) loss to earnings |
(1.0 | ) | 3.7 | (1.0 | ) | 3.7 | ||||||||
Unrealized net gain (loss) on cash flow hedges, net of tax |
17.5 | (17.5 | ) | 7.3 | (3.7 | ) | ||||||||
Comprehensive income |
$ | 37.9 | $ | 76.8 | $ | 192.5 | $ | 136.9 | ||||||
The tax effect on the unrealized net loss on investments in unconsolidated affiliates was $0.8 million and $1.0 million for the three and nine months ended September 30, 2011, respectively, and $0.1 million for both the three and nine months ended September 30, 2010. The tax effect on the unrealized net gain (loss) on cash flow hedges was $(11.4) million and $(4.7) million for the three and nine months ended September 30, 2011, respectively, and $11.4 million and $2.4 million for the three and nine months ended September 30, 2010, respectively.
15
14. EARNINGS PER SHARE
Basic earnings per share is computed by dividing net income by the weighted-average common shares outstanding during a period. Employee equity share options, nonvested shares and similar equity instruments granted by the Company are treated as potential common shares in computing diluted earnings per share. Diluted shares outstanding include the dilutive effect of restricted stock units and in-the-money options. The dilutive impact of the restricted stock units and in-the-money options is calculated based on the average share price for each fiscal period using the treasury stock method. Under the treasury stock method, the amount that the employee must pay for exercising stock options, the amount of compensation expense for future service that the Company has not yet recognized, and the amount of tax benefits that would be recorded in "Additional Paid-In Capital" when the award becomes deductible are assumed to be used to repurchase shares. Potential common share equivalents have been excluded where their inclusion would be anti-dilutive.
The table below presents the computation of basic and diluted earnings per share (in millions, except for per share information):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2011 | 2010 | 2011 | 2010 | ||||||||||
Basic: |
||||||||||||||
Net income |
$ | 51.6 | $ | 48.0 | $ | 173.6 | $ | 153.2 | ||||||
Weighted-average shares outstanding |
114.6 | 113.6 | 114.8 | 113.4 | ||||||||||
Basic earnings per share |
$ | 0.45 | $ | 0.42 | $ | 1.51 | $ | 1.35 | ||||||
Diluted: |
||||||||||||||
Net income |
$ | 51.6 | $ | 48.0 | $ | 173.6 | $ | 153.2 | ||||||
Weighted-average shares outstanding |
114.6 | 113.6 | 114.8 | 113.4 | ||||||||||
Dilutive effect of stock plans |
4.4 | 5.3 | 5.0 | 5.5 | ||||||||||
Dilutive weighted-average shares outstanding |
119.0 | 118.9 | 119.8 | 118.9 | ||||||||||
Diluted earnings per share |
$ | 0.43 | $ | 0.40 | $ | 1.45 | $ | 1.29 | ||||||
Stock options and restricted stock units to purchase 1.3 million and 1.7 million shares for the three months ended September 30, 2011 and 2010, respectively, and 0.9 million and 1.2 million for the nine months ended September 30, 2011 and 2010, respectively, were outstanding, but were not included in the computation of diluted earnings per share because the effect would have been anti-dilutive.
15. INCOME TAXES
The Company's effective income tax rates were 10.4% and 19.3% for the three and nine months ended September 30, 2011, respectively, and 27.5% and 22.7% for the three and nine months ended September 30, 2010, respectively. The effective income tax rates for the three and nine months ended September 30, 2011 included a $6.9 million and $9.4 million tax benefit, respectively, related to rulings made by the tax authorities in Switzerland. The effective income tax rates for the three and nine months ended September 30, 2010 were calculated without the benefit of the federal research credit as it was not reinstated until December 2010. In addition, the income tax rate for the nine months ended September 30, 2010 included a $9.8 million tax benefit resulting from a partial settlement of a prior year tax audit.
The Company strives to resolve open matters with each tax authority at the examination level and could reach agreement with a tax authority at any time. While the Company has accrued for matters it
16
believes are more likely than not to require settlement, the final outcome with a tax authority may result in a tax liability that is more or less than that reflected in the consolidated condensed financial statements. Furthermore, the Company may later decide to challenge any assessments, if made, and may exercise its right to appeal. The uncertain tax positions are reviewed quarterly and adjusted as events occur that affect potential liabilities for additional taxes, such as lapsing of applicable statutes of limitations, proposed assessments by tax authorities, negotiations between tax authorities, identification of new issues and issuance of new legislation, regulations or case law.
As of September 30, 2011 and December 31, 2010, the liability for income taxes associated with uncertain tax positions was $72.2 million and $55.1 million, respectively. These liabilities could be reduced by $8.0 million and $4.7 million, respectively, from offsetting tax benefits associated with the correlative effects of potential transfer pricing adjustments, state income taxes and timing adjustments. The net amounts of $64.2 million and $50.4 million, respectively, if not required, would favorably affect the Company's effective tax rate.
All material state, local and foreign income tax matters have been concluded for years through 2005. The Internal Revenue Service ("IRS") has completed its examination of the 2007 and 2008 tax years for all matters except for certain transfer pricing issues. The Company has entered the appeals process for those transfer pricing issues. The Company had its opening conference with the IRS related to the examination of its 2009 and 2010 tax years during the second quarter of 2011.
16. SEGMENT INFORMATION
Edwards Lifesciences conducts operations worldwide and is managed in the following geographical regions: United States, Europe, Japan and Rest of World. All regions sell products that are used to treat advanced cardiovascular disease. Net sales by geographic area are based on the location of the customer.
The table below presents information about Edwards Lifesciences' reportable segments (in millions):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2011 | 2010 | 2011 | 2010 | ||||||||||
Segment Net Sales |
||||||||||||||
United States |
$ | 150.5 | $ | 140.1 | $ | 450.9 | $ | 423.1 | ||||||
Europe |
128.9 | 109.2 | 409.0 | 333.2 | ||||||||||
Japan |
53.3 | 53.8 | 167.9 | 160.0 | ||||||||||
Rest of world |
50.1 | 41.9 | 147.9 | 121.9 | ||||||||||
Total segment net sales |
$ | 382.8 | $ | 345.0 | $ | 1,175.7 | $ | 1,038.2 | ||||||
Segment Pre-Tax Income |
||||||||||||||
United States |
$ | 76.3 | $ | 75.6 | $ | 237.2 | $ | 232.8 | ||||||
Europe |
52.4 | 40.7 | 177.2 | 125.6 | ||||||||||
Japan |
23.6 | 25.3 | 78.9 | 73.9 | ||||||||||
Rest of world |
15.4 | 13.1 | 44.8 | 35.4 | ||||||||||
Total segment pre-tax income |
$ | 167.7 | $ | 154.7 | $ | 538.1 | $ | 467.7 | ||||||
17
The table below presents reconciliations of segment net sales to consolidated net sales and segment pre-tax income to consolidated pre-tax income (in millions):
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2011 | 2010 | 2011 | 2010 | ||||||||||
Net Sales Reconciliation |
||||||||||||||
Segment net sales |
$ | 382.8 | $ | 345.0 | $ | 1,175.7 | $ | 1,038.2 | ||||||
Foreign currency |
29.9 | 3.9 | 72.7 | 16.4 | ||||||||||
Consolidated net sales |
$ | 412.7 | $ | 348.9 | $ | 1,248.4 | $ | 1,054.6 | ||||||
Pre-Tax Income Reconciliation |
||||||||||||||
Segment pre-tax income |
$ | 167.7 | $ | 154.7 | $ | 538.1 | $ | 467.7 | ||||||
Unallocated amounts: |
||||||||||||||
Corporate items |
(109.8 | ) | (92.7 | ) | (330.2 | ) | (269.0 | ) | ||||||
Special charges, net |
| (3.9 | ) | (4.0 | ) | (12.2 | ) | |||||||
Interest (expense) income, net |
| (0.4 | ) | 0.3 | (1.1 | ) | ||||||||
Foreign currency |
(0.3 | ) | 8.5 | 10.8 | 12.7 | |||||||||
Consolidated pre-tax income |
$ | 57.6 | $ | 66.2 | $ | 215.0 | $ | 198.1 | ||||||
Enterprise-Wide Information
Enterprise-wide information is based on foreign exchange rates used in the Company's consolidated financial statements.
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
|||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
2011 | 2010 | 2011 | 2010 | |||||||||
|
(in millions) |
||||||||||||
Net Sales by Geographic Area |
|||||||||||||
United States |
$ | 150.5 | $ | 140.1 | $ | 450.9 | $ | 423.1 | |||||
International |
262.2 | 208.8 | 797.5 | 631.5 | |||||||||
|
$ | 412.7 | $ | 348.9 | $ | 1,248.4 | $ | 1,054.6 | |||||
Net Sales by Major Product and Service Area |
|||||||||||||
Heart Valve Therapy |
$ | 246.1 | $ | 200.6 | $ | 754.1 | $ | 612.1 | |||||
Critical Care |
126.7 | 111.0 | 375.0 | 326.6 | |||||||||
Cardiac Surgery Systems |
26.9 | 23.7 | 80.3 | 75.0 | |||||||||
Vascular |
13.0 | 13.6 | 39.0 | 40.9 | |||||||||
|
$ | 412.7 | $ | 348.9 | $ | 1,248.4 | $ | 1,054.6 | |||||
|
September 30, 2011 |
December 31, 2010 |
|||||
---|---|---|---|---|---|---|---|
|
(in millions) |
||||||
Long-Lived Tangible Assets by Geographic Area |
|||||||
United States |
$ | 206.8 | $ | 180.5 | |||
International |
104.2 | 102.3 | |||||
|
$ | 311.0 | $ | 282.8 | |||
18
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
This report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The Company (as defined below in "Overview") intends the forward-looking statements contained in this report to be covered by the safe harbor provisions of such Acts. All statements other than statements of historical fact in this report or referred to or incorporated by reference into this report are "forward-looking statements" for purposes of these sections. These statements include, among other things, any predictions of earnings, revenues, expenses or other financial items, plans or expectations with respect to development activities, clinical trials or regulatory approvals, any statements of plans, strategies and objectives of management for future operations, any statements concerning the Company's future operations, financial conditions and prospects, and any statements of assumptions underlying any of the foregoing. These statements can sometimes be identified by the use of the forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "goal," "continue," "seek," "pro forma," "forecast," "intend," "guidance," "optimistic," "aspire," "confident," other forms of these words or similar words or expressions or the negative thereof. Investors are cautioned not to unduly rely on such forward-looking statements. These forward-looking statements are subject to substantial risks and uncertainties that could cause the Company's results or future business, financial condition, results of operations or performance to differ materially from the Company's historical results or those expressed or implied in any forward-looking statements contained in this report. Investors should carefully review the information contained in, or incorporated by reference into, the Company's annual report on Form 10-K for the year ended December 31, 2010 and subsequent reports on Forms 10-Q and 8-K for a description of certain of these risks and uncertainties. These forward-looking statements speak only as of the date on which they are made and the Company does not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. If the Company does update or correct one or more of these statements, investors and others should not conclude that the Company will make additional updates or corrections.
Overview
Edwards Lifesciences Corporation ("Edwards Lifesciences" or the "Company") is a global leader in products and technologies designed to treat advanced cardiovascular disease. The Company is focused specifically on technologies that treat structural heart disease and critically ill patients.
The products and technologies provided by Edwards Lifesciences are categorized into four main areas: Heart Valve Therapy; Critical Care; Cardiac Surgery Systems; and Vascular.
Edwards Lifesciences' Heart Valve Therapy portfolio is comprised of tissue heart valves and heart valve repair products. A pioneer in the development and commercialization of heart valve products, Edwards Lifesciences is the world's leading manufacturer of tissue heart valves and repair products used to replace or repair a patient's diseased or defective heart valve. In the Critical Care area, Edwards Lifesciences is a world leader in hemodynamic monitoring systems used to measure a patient's cardiovascular function, and in disposable pressure transducers. The Company's Cardiac Surgery Systems portfolio comprises a diverse line of products for use during cardiac surgery including cannulae, embolic protection devices and other products used during cardiopulmonary bypass and minimally invasive surgical procedures. Edwards Lifesciences' Vascular portfolio includes a line of balloon catheter-based products, surgical clips and inserts.
The healthcare marketplace continues to be competitive with strong global and local competitors. The Company competes with many companies, ranging from small start-up enterprises to companies that are larger and more established than Edwards Lifesciences with access to significant financial resources. Furthermore, rapid product development and technological change characterize the market in which the Company competes. Global demand for healthcare is increasing as the population ages. There is mounting pressure to contain healthcare costs in the face of this increasing demand, which has
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resulted in pricing and market share pressures. The cardiovascular segment of the medical device industry is dynamic, and technology, cost-of-care considerations, regulatory reform, industry and customer consolidation, and evolving patient needs are expected to continue to drive change.
New Accounting Standards Not Yet Adopted
In May 2011, the Financial Accounting Standards Board ("FASB") issued an amendment to the accounting guidance on fair value measurements to ensure that United States generally accepted accounting principles and International Financial Reporting Standards have common requirements for fair value measurement and disclosures, including a consistent definition of fair value. The guidance is effective for interim and annual periods beginning on or after December 15, 2011. The Company does not expect the adoption of this guidance will have a material impact on its consolidated financial statements.
In June 2011, the FASB issued an amendment to the accounting guidance on the presentation of comprehensive income. The guidance eliminates the option to present components of other comprehensive income as part of the statement of changes in stockholders' equity, and instead requires that all nonowner changes in stockholders' equity be presented in either a single continuous statement of comprehensive income or in two separate but consecutive statements. The guidance is effective for fiscal years, and interim periods within those years, beginning after December 15, 2011, with early adoption permitted.
In September 2011, the FASB issued an amendment to the accounting guidance on goodwill to permit an entity to first assess qualitative factors to determine whether it is more likely than not that the fair value of a reporting unit is less than its carrying amount as a basis for determining whether it is necessary to perform the two-step goodwill impairment test. The guidance is effective for annual and interim goodwill impairment tests performed for fiscal years beginning after December 15, 2011, with early adoption permitted. The Company does not expect the adoption of this guidance will have a material impact on its consolidated financial statements.
Results of Operations
Net Sales Trends
(dollars in millions)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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Percent Change |
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Percent Change |
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2011 | 2010 | Change | 2011 | 2010 | Change | ||||||||||||||||||||
United States |
$ | 150.5 | $ | 140.1 | $ | 10.4 | 7.5 | % | $ | 450.9 | $ | 423.1 | $ | 27.8 | 6.6 | % | ||||||||||
International |
262.2 | 208.8 | 53.4 | 25.6 | % | 797.5 | 631.5 | 166.0 | 26.3 | % | ||||||||||||||||
Total net sales |
$ | 412.7 | $ | 348.9 | $ | 63.8 | 18.3 | % | $ | 1,248.4 | $ | 1,054.6 | $ | 193.8 | 18.4 | % | ||||||||||
In the United States, the $10.4 million and $27.8 million increases in net sales for the three and nine months ended September 30, 2011 were due primarily to:
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International net sales increased $53.4 million and $166.0 million for the three and nine months ended September 30, 2011 due primarily to:
The impact of foreign currency exchange rate fluctuations on net sales is not necessarily indicative of the impact on net income due to the corresponding effect of foreign currency exchange rate fluctuations on international manufacturing and operating costs and the Company's hedging activities. For more information see Item 3, "Quantitative and Qualitative Disclosures About Market Risk."
Net Sales by Product Line
(dollars in millions)
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Three Months Ended September 30, |
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Nine Months Ended September 30, |
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Percent Change |
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Percent Change |
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2011 | 2010 | Change | 2011 | 2010 | Change | ||||||||||||||||||||
Heart Valve Therapy |
$ | 246.1 | $ | 200.6 | $ | 45.5 | 22.7 | % | $ | 754.1 | $ | 612.1 | $ | 142.0 | 23.2 | % | ||||||||||
Critical Care |
126.7 | 111.0 | 15.7 | 14.2 | % | 375.0 | 326.6 | 48.4 | 14.8 | % | ||||||||||||||||
Cardiac Surgery Systems |
26.9 | 23.7 | 3.2 | 13.2 | % | 80.3 | 75.0 | 5.3 | 7.1 | % | ||||||||||||||||
Vascular |
13.0 | 13.6 | (0.6 | ) | (4.4 | )% | 39.0 | 40.9 | (1.9 | ) | (4.8 | )% | ||||||||||||||
Total net sales |
$ | 412.7 | $ | 348.9 | $ | 63.8 | 18.3 | % | $ | 1,248.4 | $ | 1,054.6 | $ | 193.8 | 18.4 | % | ||||||||||
Heart Valve Therapy
Net sales of Heart Valve Therapy products for the three and nine months ended September 30, 2011 increased by $45.5 million and $142.0 million, respectively, due primarily to:
The Company expects that its transcatheter heart valves will continue to be a strong contributor to 2011 sales. In November 2011, the Company received approval from the United States Food and Drug Administration ("FDA") for the transfemoral delivery of the Edwards SAPIEN transcatheter heart valve for treatment of inoperable patients with severe symptomatic aortic stenosis. During the second quarter of 2011, the Company received regulatory approval and initiated its launch of the Carpentier-Edwards
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Physio Tricuspid annuloplasty ring in the United States and Europe. In Japan, the Company obtained approval of its Carpentier-Edwards PERIMOUNT Magna Aortic Ease valve in July 2011, and introduced this product in the third quarter of 2011. In Europe, the Company expects to receive CE Mark in the fourth quarter of 2011 of EDWARDS INTUITY, its minimally invasive aortic valve surgery system. In the United States, the Company remains hopeful for Investigational Device Exemption ("IDE") approval for the clinical trial of EDWARDS INTUITY in the fourth quarter of 2011.
Critical Care
Net sales of Critical Care products for the three and nine months ended September 30, 2011 increased by $15.7 million and $48.4 million, respectively, due primarily to:
During the fourth quarter of 2010, the Company launched, outside of the United States, the VolumeView System, which broadens the Company's product offering in the medical intensive care unit. At the same time, the Company launched the EV1000 Clinical Platform, a new hardware platform with a simpler, more intuitive informational display. The Company obtained regulatory clearance for the sale of these products in the United States in the second quarter of 2011.
The Company has a collaboration agreement with DexCom, Inc. to develop products for continuously monitoring blood glucose levels in patients hospitalized for a variety of conditions. The Company's recent design enhancements to its second generation product now require a more extensive regulatory review in Europe. The Company anticipates obtaining CE Mark on the second generation product in the second half of 2012.
Cardiac Surgery Systems
Net sales of Cardiac Surgery Systems products for the three and nine months ended September 30, 2011 increased by $3.2 million and $5.3 million, respectively, due primarily to foreign currency exchange rate fluctuations, which increased net sales by $1.2 million and $2.7 million, and specialty cannula products, which increased net sales by $0.9 million and $2.7 million, respectively. Also, in the three month period, minimally invasive surgery products increased net sales by $1.2 million.
Vascular
Net sales of Vascular products for the three and nine months ended September 30, 2011 decreased by $0.6 million and $1.9 million, respectively, due primarily to the Company's discontinued distribution of artificial implantable grafts during the first quarter of 2011.
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Gross Profit
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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2011 | 2010 | Change | 2011 | 2010 | Change | |||||||||||||
Gross profit as a percentage of net sales |
69.6 | % | 72.5 | % | (2.9) pts. | 70.3 | % | 72.0 | % | (1.7) pts. |
The 2.9 and 1.7 percentage point decreases in gross profit as a percentage of net sales for the three and nine months ended September 30, 2011, respectively, were driven primarily by:
partially offset by:
Selling, General and Administrative (SG&A) Expenses
(dollars in millions)
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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2011 | 2010 | Change | 2011 | 2010 | Change | |||||||||||||
SG&A expenses |
$ | 165.5 | $ | 133.0 | $ | 32.5 | $ | 479.0 | $ | 407.6 | $ | 71.4 | |||||||
SG&A expenses as a percentage of net sales |
40.1 | % | 38.1 | % | 2.0 pts. | 38.4 | % | 38.6 | % | (0.2) pts. |
The increase in SG&A expenses for the three and nine months ended September 30, 2011 was due primarily to higher sales and marketing expenses in the United States and Europe, mainly to support the transcatheter heart valve program, including preparation for the launch in the United States. Foreign currency rate fluctuations increased SG&A expenses by $9.9 million and $19.8 million, respectively, due to the strengthening of various currencies against the United States dollar, primarily the Euro and the Japanese yen.
Research and Development Expenses
(dollars in millions)
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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2011 | 2010 | Change | 2011 | 2010 | Change | |||||||||||||
Research and development expenses |
$ | 61.7 | $ | 52.7 | $ | 9.0 | $ | 185.6 | $ | 148.5 | $ | 37.1 | |||||||
Research and development expenses as a percentage of net sales |
15.0 | % | 15.1 | % | (0.1) pts. | 14.9 | % | 14.1 | % | 0.8 pts. |
The increase in research and development expenses for the three and nine months ended September 30, 2011 was due primarily to additional investments in clinical studies and development efforts in the transcatheter heart valve program.
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The following are the developments related to the Company's transcatheter heart valve program:
Special Charges, net
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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2011 | 2010 | 2011 | 2010 | ||||||||||
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(in millions) |
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Greece receivables reserve |
$ | | $ | | $ | 4.0 | $ | | ||||||
Investment impairment |
| 3.9 | | 3.9 | ||||||||||
MONARC program discontinuation |
| | | 8.3 | ||||||||||
Special charges, net |
$ | | $ | 3.9 | $ | 4.0 | $ | 12.2 | ||||||
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Greece Receivables Reserve
In June 2011, the Company recorded a $4.0 million charge to reflect the increased collection risk associated with its receivables in Greece.
Realignment Expenses, net
In December 2010, the Company recorded a $7.2 million charge related primarily to severance expenses associated with a global workforce realignment impacting 84 employees. As of September 30, 2011, the Company's remaining severance obligations of $1.5 million are expected to be substantially paid by March 2012.
Investment Impairment
In September 2010, the Company recorded a $3.9 million charge related to the other-than-temporary impairment of two non-strategic investments in unconsolidated affiliates. The Company concluded that the impairment of these investments was other-than-temporary based upon the continuing duration and severity of the impairment.
MONARC Program Discontinuation
During the second quarter of 2010, the Company decided to discontinue its MONARC transcatheter mitral valve program due to slow enrollment in the EVOLUTION II trial. As a result, the Company recorded an $8.3 million charge consisting of a $7.6 million impairment of intangible assets associated with the program and $0.7 million of clinical trial costs that will continue to be incurred under a contractual obligation that existed prior to the discontinuation date.
Interest Expense (Income), net
(in millions)
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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2011 | 2010 | Change | 2011 | 2010 | Change | ||||||||||||||
Interest expense |
$ | 1.0 | $ | 0.7 | $ | 0.3 | $ | 2.2 | $ | 1.9 | $ | 0.3 | ||||||||
Interest income |
(1.0 | ) | (0.3 | ) | (0.7 | ) | (2.5 | ) | (0.8 | ) | (1.7 | ) | ||||||||
Interest expense (income), net |
$ | | $ | 0.4 | $ | (0.4 | ) | $ | (0.3 | ) | $ | 1.1 | $ | (1.4 | ) | |||||
The increase in interest expense for the three and nine months ended September 30, 2011 resulted primarily from a higher average debt balance compared to the prior year period. The increase in interest income for the three and nine months ended September 30, 2011 resulted primarily from higher average interest rates and higher cash and short-term investment balances.
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Other Expense (Income), net
(in millions)
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Three Months Ended September 30, |
Nine Months Ended September 30, |
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2011 | 2010 | 2011 | 2010 | ||||||||||
Foreign exchange losses (gains), net |
$ | 3.1 | $ | (1.7 | ) | $ | 1.7 | $ | (1.7 | ) | ||||
(Gain) loss on investments in unconsolidated affiliates |
(0.9 | ) | 0.2 | (5.5 | ) | (1.1 | ) | |||||||
Earn-out payments |
| (1.5 | ) | (1.0 | ) | (4.5 | ) | |||||||
Other |
0.1 | (0.1 | ) | (0.3 | ) | (0.4 | ) | |||||||
Other expense (income), net |
$ | 2.3 | $ | (3.1 | ) | $ | (5.1 | ) | $ | (7.7 | ) | |||
The foreign exchange losses (gains) relate to the foreign currency fluctuations in the Company's global trade and intercompany receivable and payable balances. Foreign exchange fluctuations (primarily the Euro) resulted in a net loss in 2011.
The gain (loss) on investments in unconsolidated affiliates primarily represents the Company's net share of gains and losses in investments accounted for under the equity method, and realized gains and losses on the Company's available-for-sale and cost method investments.
In September 2009, the Company sold its hemofiltration product line. In connection with the transaction, the Company was entitled to earn-out payments up to $9.0 million based on certain revenue objectives to be achieved by the buyer over the two years following the sale. As of March 31, 2011, all $9.0 million of earn-out payments had been earned.
Provision for Income Taxes
The provision for income taxes consists of provisions for federal, state and foreign income taxes. The Company operates in an international environment with significant operations in various locations outside the United States, which have statutory tax rates lower than the United States tax rate. Accordingly, the consolidated income tax rate is a composite rate reflecting the earnings in the various locations and the applicable rates. The Company's effective income tax rates were 10.4% and 19.3% for the three and nine months ended September 30, 2011, respectively, and 27.5% and 22.7% for the three and nine months ended September 30, 2010, respectively. The effective income tax rates for the three and nine months ended September 30, 2011 included a $6.9 million and $9.4 million tax benefit, respectively, related to rulings made by the tax authorities in Switzerland. The effective income tax rates for the three and nine months ended September 30, 2010 were calculated without the benefit of the federal research credit as it was not reinstated until December 2010. In addition, the income tax rate for the nine months ended September 30, 2010 included a $9.8 million tax benefit resulting from a partial settlement of a prior year tax audit.
The Company strives to resolve open matters with each tax authority at the examination level and could reach agreement with a tax authority at any time. While the Company has accrued for matters it believes are more likely than not to require settlement, the final outcome with a tax authority may result in a tax liability that is more or less than that reflected in the consolidated condensed financial statements. Furthermore, the Company may later decide to challenge any assessments, if made, and may exercise its right to appeal. The uncertain tax positions are reviewed quarterly and adjusted as events occur that affect potential liabilities for additional taxes, such as lapsing of applicable statutes of limitations, proposed assessments by tax authorities, negotiations between tax authorities, identification of new issues and issuance of new legislation, regulations or case law. Management believes that adequate amounts of tax and related penalty and interest have been provided in income tax expense for any adjustments that may result from these uncertain tax positions.
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As of September 30, 2011 and December 31, 2010, the liability for income taxes associated with uncertain tax positions was $72.2 million and $55.1 million, respectively. These liabilities could be reduced by $8.0 million and $4.7 million, respectively, from offsetting tax benefits associated with the correlative effects of potential transfer pricing adjustments, state income taxes and timing adjustments. The net amounts of $64.2 million and $50.4 million, respectively, if not required, would favorably affect the Company's effective tax rate.
Liquidity and Capital Resources
The Company's sources of cash liquidity include cash on hand and cash equivalents, amounts available under credit facilities and cash from operations. The Company believes that these sources are sufficient to fund the current requirements of working capital, capital expenditures and other financial commitments. The Company further believes that it has the financial flexibility to attract long-term capital to fund short-term and long-term growth objectives. However, no assurances can be given that such long-term capital will be available to Edwards Lifesciences on favorable terms, or at all.
As of September 30, 2011, cash and cash equivalents held outside the United States were approximately $391.9 million, and have historically been used to fund international operations. The Company believes that cash and cash equivalents held in the United States, in addition to amounts available under credit facilities and cash from operations, are sufficient to fund its United States operating requirements. The majority of cash and cash equivalents held outside the United States relate to undistributed earnings of certain of the Company's foreign subsidiaries which is considered to be indefinitely reinvested by the Company. Repatriations of cash and cash equivalents held outside the United States are subject to restrictions in certain jurisdictions and may be subject to withholding and other taxes. The potential tax liability related to any repatriation would be dependent on the facts and circumstances that would exist at the time such repatriation is made and the complexities of the tax laws of the United States and the respective foreign jurisdictions.
In July 2011, Edwards Lifesciences entered into a Four-Year Credit Agreement ("the Credit Facility") which matures on July 29, 2015. The proceeds of the Credit Facility were used to refinance the Company's previous Five-Year Unsecured Revolving Credit Agreement ("the Credit Agreement"). The Credit Facility provides up to an aggregate of $500.0 million in borrowings in multiple currencies. Borrowings generally bear interest at the London interbank offering rate ("LIBOR") plus 0.875%, subject to adjustment for leverage ratio changes as defined in the Credit Facility. The Company also pays a facility fee of 0.125% on the entire $500.0 million facility whether or not drawn. The facility fee is also subject to adjustment for leverage ratio changes. All amounts outstanding under the Credit Facility have been classified as long-term obligations as these borrowings are expected to be refinanced pursuant to the Credit Facility. As of September 30, 2011, borrowings of $175.0 million were outstanding under the Credit Facility. The Credit Facility is unsecured and contains various financial and other covenants, including a maximum leverage ratio and a minimum interest coverage ratio, as defined in the Credit Facility. The Company was in compliance with all covenants at September 30, 2011.
In March 2011, the Company acquired all the outstanding shares of Embrella Cardiovascular, Inc. ("Embrella"), including shares already owned by the Company, for an aggregate purchase price of $42.6 million. The purchase price was funded with cash on hand and borrowings under the Credit Agreement. Embrella is a start-up medical device company developing a device for cerebral embolic protection during cardiovascular procedures.
In February 2010, the Board of Directors approved a stock repurchase program authorizing the Company to purchase on the open market and in privately negotiated transactions up to $500.0 million of the Company's common stock. During the nine months ended September 30, 2011, the Company repurchased 3.3 million shares at an aggregate cost of $260.1 million and had remaining authority
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under the February 2010 program to purchase $137.9 million of the Company's common stock. In September 2011, the Board of Directors approved a new stock repurchase program authorizing the Company to purchase on the open market and in privately negotiated transactions up to an additional $500.0 million of the Company's common stock, for a total availability of $637.9 million as of September 30, 2011. The Company has not yet repurchased any shares under the new stock repurchase plan. In addition to shares repurchased under the stock repurchase program, the Company also acquired shares to satisfy tax withholding obligations in connection with the vesting of restricted stock issued to employees.
At September 30, 2011, there had been no material changes in the Company's significant contractual obligations and commercial commitments as disclosed in its Annual Report on Form 10-K for the year ended December 31, 2010.
Net cash flows provided by operating activities of $171.4 million for the nine months ended September 30, 2011 increased $14.0 million over the same period a year ago due primarily to improved operating performance, partially offset by higher working capital needs.
Net cash used in investing activities of $81.4 million for the nine months ended September 30, 2011 consisted primarily of a $42.6 million payment associated with the acquisition of Embrella, and capital expenditures of $50.6 million.
Net cash used in investing activities of $38.4 million for the nine months ended September 30, 2010 consisted primarily of capital expenditures of $40.1 million.
Net cash used in financing activities of $38.2 million for the nine months ended September 30, 2011 consisted primarily of purchases of treasury stock of $263.3 million, partially offset by net proceeds from debt of $128.8 million, proceeds from stock plans of $48.6 million, and the excess tax benefit from stock plans of $47.0 million.
Net cash used in financing activities of $77.3 million for the nine months ended September 30, 2010 consisted primarily of purchases of treasury stock of $200.0 million, partially offset by net proceeds from debt of $9.2 million, proceeds from stock plans of $73.8 million, and the excess tax benefit from stock plans of $42.0 million.
Critical Accounting Policies
The consolidated condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States which require the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the consolidated financial statements and revenues and expenses during the periods reported. Actual results could differ from those estimates. Information with respect to the Company's critical accounting policies which the Company believes could have the most significant effect on the Company's reported results and require subjective or complex judgments by management is contained on pages 37-41 in Item 7, "Management's Discussion and Analysis of Financial Condition and Results of Operations," of the Company's Annual Report on Form 10-K for the year ended December 31, 2010. Management believes that at September 30, 2011, there had been no material changes to this information.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Interest Rate, Foreign Currency and Credit Risk
For a complete discussion of the Company's exposure to interest rate, foreign currency and credit risk, refer to Item 7A "Quantitative and Qualitative Disclosures About Market Risk" on pages 42-43 of the Company's Annual Report on Form 10-K for the year ended December 31, 2010. There have been no significant changes from the information discussed therein.
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Concentrations of Credit Risk
In the normal course of business, Edwards Lifesciences provides credit to customers in the healthcare industry, performs credit evaluations of these customers and maintains allowances for potential credit losses which have historically been adequate compared to actual losses. The Company continues to do business with foreign governments in certain European countries that have experienced a deterioration in credit and economic conditions. These conditions have resulted in, and may continue to result in, an increase in the average length of time that it takes to collect accounts receivable outstanding in these countries. In addition, the Company may also be impacted by declines in sovereign credit ratings or sovereign defaults in these countries.
In June 2011, the Company recorded a $4.0 million charge to reflect the increased collection risk associated with its receivables in Greece. A significant further decline in sovereign credit ratings or a default in Greece, or in other European countries, may decrease the likelihood that the Company will collect these accounts receivable, which could result in a negative impact to the Company's operating results.
Investment Risk
Edwards Lifesciences is exposed to investment risks related to changes in the fair values of its investments. The Company invests in equity instruments of public and private companies. These investments are classified in "Investments in Unconsolidated Affiliates" on the consolidated condensed balance sheets.
As of September 30, 2011, Edwards Lifesciences had $21.4 million of investments in equity instruments of other companies and had recorded unrealized gains of $0.5 million on these investments in "Accumulated Other Comprehensive Loss," net of tax. Should these companies experience a decline in financial condition or fail to meet certain development milestones, the decline in the investments' value may be considered other-than-temporary and impairment charges may be necessary.
Item 4. Controls and Procedures
The Company's management, including the Chief Executive Officer and the Chief Financial Officer, conducted an evaluation of the effectiveness of the Company's disclosure controls and procedures as of September 30, 2011. Based on their evaluation, the Chief Executive Officer and the Chief Financial Officer have concluded that such controls and procedures are designed at a reasonable assurance level and are effective in providing reasonable assurance that the information required to be disclosed by the Company in the reports it files or submits under the Securities Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the Securities and Exchange Commission and that such information is accumulated and communicated to the Company's management, including the Chief Executive Officer and the Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. There have been no changes in the Company's internal controls over financial reporting during the quarter ended September 30, 2011 that have materially affected, or are reasonably likely to materially affect, the Company's internal control over financial reporting.
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In February 2008, Edwards Lifesciences filed a lawsuit against CoreValve, Inc. ("CoreValve") in the United States District Court for the District of Delaware alleging that its ReValving System infringes three of the Company's U.S. Andersen patents, later narrowed to one patent ("the '552 patent"). CoreValve was acquired by Medtronic, Inc. ("Medtronic") in April 2009. In April 2010, a federal jury found that patent to be valid and found that CoreValve willfully infringes it. The jury also awarded Edwards $73.9 million in damages. In February 2011, the District Court reaffirmed the jury decision and ruled that Edwards is entitled to recover additional damages due to CoreValve's continued infringing sales from the trial through the life of the patent, plus interest. In the same ruling, the court denied Edwards' motions for a permanent injunction, as well as its motion for increased damages relating to CoreValve's willful infringement. Both Edwards and CoreValve have appealed. A second lawsuit is pending in the same court against CoreValve and Medtronic alleging infringement of three U.S. Andersen patents. In September 2010, the United States Patent and Trademark Office granted Medtronic's third request to reexamine the validity of the claim of the '552 patent and in July 2011 confirmed the validity of that patent.
In June 2011, Medtronic filed a lawsuit in the United States District Court for the District of Minnesota alleging that certain surgical valve holders and a surgical embolic filter device infringe its patents. Medtronic also filed another lawsuit in the United States District Court for the Central District of California alleging that the Edwards SAPIEN transcatheter heart valve infringes a Medtronic patent. In the California action, Edwards has counterclaimed against Medtronic, alleging that the Medtronic CoreValve heart valve infringes Edwards' U.S. Letac-Cribier transcatheter heart valve patent.
In March and September 2010, the Company received grand jury subpoenas for documents from the United States Attorney's Office in the Central District of California in connection with an investigation by the Food and Drug Administration. The subpoenas to the Company seek records relating to the Vigilance I Monitor model with software release 5.3 that was the subject of a voluntary field recall by the Company in June 2006. The Company is cooperating fully with the investigation.
In addition, Edwards Lifesciences is or may be a party to, or may otherwise be responsible for, pending or threatened lawsuits related primarily to products and services currently or formerly manufactured or performed, as applicable, by Edwards Lifesciences. Such cases and claims raise difficult and complex factual and legal issues and are subject to many uncertainties, including, but not limited to, the facts and circumstances of each particular case or claim, the jurisdiction in which each suit is brought, and differences in applicable law. Upon resolution of any such legal matter or other claim, Edwards Lifesciences may incur charges in excess of established reserves. The Company is not able to estimate the amount or range of any loss for legal contingencies for which there is no reserve or additional loss for matters already reserved. While any such charge could have a material adverse impact on Edwards Lifesciences' net income or cash flows in the period in which it is recorded or paid, management does not believe that any such charge relating to any currently pending lawsuit would have a material adverse effect on Edwards Lifesciences' financial position, results of operations or liquidity.
Edwards Lifesciences is subject to various environmental laws and regulations both within and outside of the United States. The operations of Edwards Lifesciences, like those of other medical device companies, involve the use of substances regulated under environmental laws, primarily in manufacturing and sterilization processes. While it is difficult to quantify the potential impact of continuing compliance with environmental protection laws, management believes that such compliance will not have a material impact on Edwards Lifesciences' financial position, results of operations or liquidity.
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Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Period
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Total Number of Shares (or Units) Purchased(a) |
Average Price Paid per Share (or Unit) |
Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs |
Maximum Number (or Approximate Dollar Value) of Shares that May Yet Be Purchased Under the Plans or Programs (in millions)(b) |
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July 1, 2011 through July 31, 2011 |
219,619 | $ | 86.67 | 215,000 | $ | 223.1 | |||||||
August 1, 2011 through August 31, 2011 |
1,014,900 | 68.85 | 1,014,400 | 153.2 | |||||||||
September 1, 2011 through September 30, 2011 |
206,237 | 74.48 | 206,200 | 637.9 | |||||||||
Total |
1,440,756 | 72.38 | 1,435,600 | ||||||||||
Exhibits required by Item 601 of Regulation S-K are listed in the Exhibit Index hereto and include the following:
10.1 | Edwards Lifesciences Corporation Executive Deferred Compensation Plan (as amended and restated effective July 6, 2011) | ||
31.1 | Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | ||
31.2 | Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | ||
32 | Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | ||
101 | * | The following financial statements from Edwards Lifesciences' Quarterly Report on Form 10-Q for the quarter ended September 30, 2011, formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Condensed Balance Sheets, (ii) the Consolidated Condensed Statements of Operations, (iii) the Consolidated Condensed Statements of Cash Flows, and (iv) Notes to Consolidated Condensed Financial Statements |
31
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
EDWARDS LIFESCIENCES CORPORATION (Registrant) |
||||
Date: November 8, 2011 |
By: |
/s/ THOMAS M. ABATE Thomas M. Abate Corporate Vice President, Chief Financial Officer (Chief Accounting Officer) |
32
EXHIBITS FILED WITH SECURITIES AND EXCHANGE COMMISSION
Exhibit No. | Description | ||
---|---|---|---|
10.1 | Edwards Lifesciences Corporation Executive Deferred Compensation Plan (as amended and restated effective July 6, 2011) | ||
31.1 | Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | ||
31.2 | Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 | ||
32 | Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | ||
101 | * | The following financial statements from Edwards Lifesciences' Quarterly Report on Form 10-Q for the quarter ended September 30, 2011, formatted in XBRL (eXtensible Business Reporting Language): (i) the Consolidated Condensed Balance Sheets, (ii) the Consolidated Condensed Statements of Operations, (iii) the Consolidated Condensed Statements of Cash Flows, and (iv) Notes to Consolidated Condensed Financial Statements |
33
EDWARDS LIFESCIENCES CORPORATION
EXECUTIVE DEFERRED COMPENSATION PLAN
(As Amended and Restated Effective July 6, 2011)
|
|
Page | |||
---|---|---|---|---|---|
ARTICLE I PURPOSE |
1 | ||||
ARTICLE II DEFINITIONS |
1 |
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2.1 |
Account |
1 |
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2.2 |
Administrative Committee |
1 |
|||
2.3 |
Base Pay |
1 |
|||
2.4 |
Beneficiary |
1 |
|||
2.5 |
Bonus |
1 |
|||
2.6 |
Code |
1 |
|||
2.7 |
Company |
1 |
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2.8 |
Compensation |
1 |
|||
2.9 |
Compensation Committee |
2 |
|||
2.10 |
Eligible Employee |
2 |
|||
2.11 |
Excess Matching Contribution |
2 |
|||
2.12 |
401(k) Plan |
2 |
|||
2.13 |
Matching Contribution |
2 |
|||
2.14 |
Participant |
2 |
|||
2.15 |
Plan Year |
2 |
|||
2.16 |
Plan Year Account |
2 |
|||
2.17 |
Separation from Service |
2 |
|||
2.18 |
Specified Employee |
2 |
|||
2.19 |
Vesting |
2 |
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ARTICLE III PARTICIPANT DEFERRALS AND MATCHING CONTRIBUTIONS |
2 |
||||
3.1 |
Deferral Elections |
2 |
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|
(a) Elections |
2 |
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|
(b) Evergreen Elections |
3 |
|||
|
(c) Election Irrevocable |
3 |
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|
(d) Late Election |
3 |
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3.2 |
Deferral Amounts |
3 |
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3.3 |
Excess Matching Contribution |
3 |
i
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Page | |||
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ARTICLE IV CREDITING OF ACCOUNTS AND EARNINGS |
4 | ||||
4.1 |
Crediting of Accounts |
4 |
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|
(a) Participant Contributions |
4 |
|||
|
(b) Excess Matching Contributions |
4 |
|||
4.2 |
Earnings |
4 |
|||
4.3 |
Account Statements |
4 |
|||
4.4 |
Vesting |
4 |
|||
ARTICLE V DISTRIBUTIONS |
4 |
||||
5.1 |
Distribution of Benefits |
4 |
|||
|
(a) Election |
4 |
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|
(b) Timing |
4 |
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(c) Form |
5 |
|||
|
(d) Subsequent Election |
5 |
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|
(e) Death of Participant |
||||
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(f) Commencement of Distribution |
5 |
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|
(g) Small Benefit Cashout |
5 |
|||
5.2 |
Special Distribution Election in 2008 |
5 |
|||
5.3 |
Effect of Payment |
5 |
|||
5.4 |
Taxation of Plan Benefits |
6 |
|||
5.5 |
Withholding and Payroll Taxes |
6 |
|||
5.6 |
Distribution Due to Unforeseeable Emergency |
6 |
|||
ARTICLE VI BENEFICIARY DESIGNATION |
6 |
||||
6.1 |
Beneficiary Designation |
6 |
|||
6.2 |
Amendments to Beneficiary Designation |
6 |
|||
6.3 |
No Beneficiary Designation |
6 |
|||
ARTICLE VII AMENDMENT AND TERMINATION OF PLAN |
7 |
||||
7.1 |
Amendment |
7 |
|||
7.2 |
Right to Terminate |
7 |
ii
|
|
Page | |||
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ARTICLE VIII MISCELLANEOUS |
7 | ||||
8.1 |
Unfunded Plan |
7 |
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8.2 |
Nonassignability |
7 |
|||
8.3 |
Claims Procedure |
7 |
|||
8.4 |
Indemnification |
8 |
|||
8.5 |
Not a Contract of Employment |
8 |
|||
8.6 |
Protective Provisions |
8 |
|||
8.7 |
Governing Law |
8 |
|||
8.8 |
Severability |
8 |
|||
8.9 |
Successors |
8 |
|||
8.10 |
Effect on Benefit Plans |
8 |
|||
8.11 |
Compliance with Code Section 409A |
8 |
iii
EDWARDS LIFESCIENCES CORPORATION
EXECUTIVE DEFERRED COMPENSATION PLAN
(As Amended and Restated Effective July 6, 2011)
This Edwards Lifesciences Corporation Deferred Compensation Plan (the "Plan") is designed to (1) offer selected employees of Edwards Lifesciences Corporation and its affiliates certain benefits that cannot be provided under the Edwards Lifesciences Corporation tax-qualified plans and (2) provide additional opportunities for selected employees to defer compensation. This Plan became effective on January 1, 2005 for (i) Compensation earned after December 31, 2004 and deferred pursuant to the provisions of this Plan and (ii) any Compensation deferred prior to January 1, 2005 under the Edwards Lifesciences Corporation Executive Option Plan but not vested on or before such date. This Plan was amended and restated, effective January 1, 2009, to conform the provisions of the plan document to the applicable requirements of Section 409A of the Internal Revenue Code, as amended (the "Code") and the Treasury Regulations issued thereunder. The Plan is hereby amended and restated effective July 6, 2011 to amend certain provisions to facilitate Plan administration.
Between January 1, 2005 and December 31, 2008, this Plan has been operated in accordance with the transitional relief established by the Treasury Department and the Internal Revenue Service under Section 409A of the Code.
This Plan is intended to be a plan that is unfunded and maintained by Edwards Lifesciences Corporation primarily for the purpose of providing deferred compensation for a select group of management or highly compensated employees within the meaning of the Employee Retirement Income Security Act of 1974, as amended ("ERISA").
2.1 Account means the account maintained under the Plan for each Participant which is credited with amounts under Article III of the Plan and adjusted periodically for investment performance under Article IV of the Plan and distributions or withdrawals in accordance with Article V. To the extent it considers necessary or appropriate, the Compensation Committee or its delegate may further divide each such Account into a series of separate subaccounts so that each category of deferred Compensation or other contribution may be credited to its own separate subcategories within that particular Account.
2.2 Administrative Committee means the Administrative Committee as defined in the 401(k) Plan.
2.3 Base Pay means the Participant's Base Pay as defined in the 401(k) Plan.
2.4 Beneficiary means the Participant's Beneficiary (as defined in Article VI) designated to receive the Participant's Accounts, if any, from the Plan, upon the death of the Participant.
2.5 Bonus means any bonus payable to the Participant under the Edwards Incentive Plan.
2.6 Code means the Internal Revenue Code of 1986, as amended.
2.7 Company means Edwards Lifesciences Corporation.
2.8 Compensation means Compensation as defined in the 401(k) Plan without regard to Section 401(a)(17) of the Code.
1
2.9 Compensation Committee means the Compensation and Governance Committee of the Board of Directors of the Company. The Compensation Committee shall have full discretionary authority to administer and interpret the Plan, to determine eligibility for Plan benefits, to select employees for Plan participation, to determine the benefit entitlement of each Participant and Beneficiary hereunder and to correct errors. The Compensation Committee may delegate one or more of its duties and responsibilities hereunder to the Administrative Committee, and unless the Compensation Committee expressly provides to the contrary, any such delegation will carry with it the Compensation Committee's full discretionary authority with respect to the delegated duties and responsibilities. In no event, however, shall the Compensation Committee delegate its authority to select the Eligible Employees who are to participate in the Plan or its authority to amend or terminate the Plan pursuant to the provisions of Article VII. Decisions of the Compensation Committee or the Administrative Committee will be final and binding on all persons.
2.10 Eligible Employee means any individual who is employed as a corporate officer of the Company and who is a U.S. employee or a U.S. expatriate. In addition, "Eligible Employee" means any other key employee of the Company or an affiliate who is designated as an Eligible Employee by the Chief Executive Officer of the Company.
2.11 Excess Matching Contribution means the difference between the Matching Contributions allocated to a Participant's 401(k) Plan Account during the Plan Year and the amount that would have been allocated if the limitations of Sections 415, 401(k), 402(g) and 401(m) of the Code, as well as the limitations of Section 401(a)(17) of the Code, were disregarded.
2.12 401(k) Plan means the Edwards Lifesciences Corporation 401(k) Savings and Investment Plan.
2.13 Matching Contribution means the Matching Contribution pursuant to the 401(k) Plan.
2.14 Participant means any Eligible Employee who has an Account balance in the Plan.
2.15 Plan Year means the calendar year.
2.16 Plan Year Account means for each Plan Year, that portion of an Eligible Employee's Account that is attributable to (i) Compensation that would have been paid in such Plan Year had payment not been deferred under this Plan and (ii) earnings credited thereto pursuant to Article IV.
2.17 Separation from Service means separation from service with the Company and all affiliates within the meaning of Code Section 409A and the regulations thereunder.
2.18 Specified Employee means a specified employee as determined under Code Section 409A pursuant to procedures established by the Compensation Committee in accordance with the applicable standards of Code Section 409A and the Treasury Regulations thereunder and applied on a consistent basis for all non-qualified deferred compensation plans subject to Code Section 409A.
2.19 Vesting has the same meaning as Vesting in the 401(k) Plan.
ARTICLE III
PARTICIPANT DEFERRALS AND MATCHING CONTRIBUTIONS
3.1 Deferral Elections.
(a) Elections. In order to participate in the Plan, an Eligible Employee must file an appropriate deferral election for that Plan Year. Such election must be made in writing during the enrollment period established by the Compensation Committee before the start of the Plan Year in which the Compensation subject to that election is to be earned in accordance with the rules and procedures established by the Compensation Committee. However, if an individual first becomes an Eligible Employee during a Plan Year, that individual may elect, within thirty (30) days after he
2
or she is first notified that he or she is eligible to participate in the Plan, to make a deferral election with respect to Compensation earned for services performed after the election is made.
(b) Evergreen Elections. An election made for a Plan Year shall remain in effect for subsequent Plan Years until changed or revoked Such "evergreen" election will become effective on the date such election becomes irrevocable under Section 3.1(c) below. An evergreen election may be terminated or modified prospectively with respect to Compensation for which such election remains revocable under Section 3.1(c) below. A Participant whose election is cancelled in accordance with Section 5.6 will be required to file a new election under this Section 3.1 in order to recommence deferrals under the Plan.
(c) Election Irrevocable. A Participant's election will become irrevocable on December 31 of the year preceding the year in which the Compensation subject to that election is to be earned. An election filed by an individual who first becomes an Eligible Employee during a Plan Year will become irrevocable at the end of the thirty (30)-day election period for such individual specified in Section 3.1(a) above. An election that has become irrevocable may not be subsequently revoked, modified or changed, except to the extent permitted under Code Section 409A and the regulations thereunder.
(d) Late Election. Except to the extent otherwise provided in Section 3.1(b), if an Eligible Employee does not make a timely election for a Plan Year, no contributions will be made under the Plan on behalf of that Eligible Employee with regard to that election for that Plan Year.
3.2 Deferral Amounts. A Participant may make a separate election to defer under the Plan with respect to each of the following amounts of earnings:
(a) A portion of his or her Compensation elected for deferral under the 401(k) Plan in excess of the annual contribution limit under Sections 401(k) and 402(g) of the Code.
(b) Any whole percentage of his or her Base Pay (with a minimum of five percent (5%)) in addition to the Base Pay being deferred pursuant to the Participant's election under Section 3.2(a).
(c) Any whole percentage of his or her Bonus earned during the Plan Year. However, in no event may the Bonus deferred under the Plan, when added to any Bonus contributed to the 401(k) Plan exceed one hundred percent (100%) of such Bonus.
The amount of each type of Compensation deferred under the Plan will be the lesser of (i) the portion or percentage of deferral elected by the Participant for such type of Compensation (calculated prior to any deductions or withholdings) or (ii) the amount of such type of Compensation remaining available after deduction of all applicable income taxes on amounts not subject to deferral and applicable employment taxes, elective deferrals for 401(k) Plan or other employee benefit plan contributions and other required reductions applicable to total Compensation.
3.3 Excess Matching Contribution. An Eligible Employee will be eligible to receive a supplemental matching contribution for a Plan Year equal to the Eligible Employee's Excess Matching Contribution for that Plan Year. Notwithstanding the foregoing, any changes in election by the Participant under the 401(k) Plan shall not increase or decrease either the elective deferrals under Section 3.2(a) or the Excess Matching Contributions under this Section 3.3 by an amount greater than the limit under Code Section 402(g) in effect for the year for the Participant, nor shall the Participant's action or inaction cause Excess Matching Contributions to exceed 100 percent (100%) of the matching amounts that would be provided under the 401(k) Plan absent any restrictions that reflect Code limits on qualified plan contributions.
3
ARTICLE IV
CREDITING OF ACCOUNTS AND EARNINGS
4.1 Crediting of Accounts.
(a) Participant Contributions. Any amounts deferred by a Participant under Section 3.2 shall be credited to his or her Account on the last business day of the calendar quarter in which those amounts would otherwise have been paid to Participant.
(b) Excess Matching Contributions. A Participant's Excess Matching Contributions, if any, will be credited to his or her Account on the last business day of the calendar quarter in which the Matching Contribution to which the Excess Matching Contribution relate would otherwise have been credited to the 401(k) Plan.
4.2 Earnings. Amounts credited to a Participant's Accounts under the Plan shall be credited with earnings and losses, at periodic intervals determined by the Compensation Committee, at a rate equal to the actual rate of return for such period of the investment fund or funds or index or indices or vehicle or vehicles selected by that Participant (in accordance with procedures established by the Compensation Committee) from a range of investment vehicles authorized by the Compensation Committee. The rate of return on investment vehicles shall be tracked solely for the purpose of computing the amount of benefits payable from the Participant's Accounts under the Plan. The Company shall not be obligated to make any actual investment. The available investment funds shall be subject to change periodically by the Compensation Committee or delegate thereof.
4.3 Account Statements. Account Statements will be generated effective as of the last day of each calendar quarter and mailed to each Participant as soon as administratively feasible. Account Statements will reflect all Account activity during the reporting quarter, including Account contributions, distributions and earnings credits.
4.4 Vesting. Subject to Section 8.1, a Participant shall be 100% Vested in his or her Account in the Plan at all times.
5.1 Distribution of Benefits.
(a) Election. Each Participant must elect, with respect to each Plan Year, the time and form in which his or her Plan Year Account and other Accounts will be distributed. Such election must be made in writing at the same time the Participant files his or her deferral election for such Plan Year pursuant to Section 3.1. An election as to time and form of payment may not be changed, except as expressly provided herein.
(b) Timing. A Participant may elect to have the vested portion of his or her Accounts distributed as soon as administratively practicable following one of the following distribution events: (i) the date of the Participant's Separation from Service, (ii) the date of the Participant's death, (iii) the date specified by the Participant in his or her election or (iv) the earliest of (i), (ii) or (iii) above elected by the Participant. Under option (iii) above, the date specified must be at least 12 months from the beginning of the Plan Year to which that Account relates. Any such distribution shall be made or begin on the designated commencement date or event or as soon as administratively practicable thereafter, but in no event later than the later of (i) the end of the calendar year in which the designated commencement date or event occurs or (ii) the fifteenth (15th) day of the third (3rd) calendar month following the occurrence of such commencement date or event.
4
(c) Form. For each type of distribution event (Separation from Service, specified date or death) elected by a Participant for distribution of his or her Accounts, the Participant may elect to have the vested portion of his or her Accounts distributed in one of the following forms: (i) a lump sum or (ii) a series of annual installments, not in excess of fifteen (15). The amount of each installment will be the remaining balance of the Participant's vested Accounts divided by the number of installments remaining (including the installment to be made).
(d) Subsequent Election. A Participant may change the distribution election in effect for an Account by submitting that change to the Compensation Committee or its delegate in writing. However, the subsequent election shall have no force or effect and shall not become effective until the expiration of the 12-month period measured from the filing date of such election. In addition, in the case of a distribution on a Separation from Service under option (i) of 5.1(b) or a scheduled distribution to be made pursuant to option (iii) of 5.1(b), such election shall be valid only if (A) such election defers any distribution for at least 5 years after the date that distribution would have otherwise been made or commenced in the absence of such subsequent election and, in the case of a scheduled distribution to be made pursuant to option (iii) of Section 5.1(b), (B) such election is made at least twelve (12) months before the date of the first of the scheduled payments. In no event may any change to the distribution election in effect for the Account result in any acceleration of the distribution of that Account.
(e) Deferred Commencement of Distribution. Notwithstanding any provision to the contrary in this Article V or any other article of this Plan, no distribution in connection with the Separation from Service by a Participant who is at the time a Specified Employee shall be made or otherwise commence prior to the earlier of (i) the expiration of the six (6)-month period measured from the date of such Separation from Service or (ii) the date of the Participant's death if such delayed commencement is otherwise required in order to avoid a permitted distribution under Code Section 409A(a)(2). Upon the expiration of the applicable deferral period, all payments deferred pursuant to this Section 5.1 (whether they would have otherwise been payable in a single sum or in installments in the absence of such deferral) shall be paid in a lump sum to the Participant, and any remaining payments due under the Plan shall be paid in accordance with the normal payment dates specified for them herein. During such deferral period, the Participant's Account shall continue to be subject to the investment return provisions of Article IV.
(f) Small Benefit Cashout. Should the aggregate present value of all the remaining unpaid installments due to a Participant who is receiving one or more installment distributions under the Plan total less than $50,000 then the Participant will receive lump sum payment of his or her Accounts within thirty (30) days thereafter.
5.2 Special Distribution Election in 2008. Notwithstanding the limitations and restrictions of Section 5.1(a), Participants may make a special election to change the time and form of the distribution of one or more of their Plan Accounts provided the election is made at least 12 months in advance of the newly elected distribution date. Such election must be made prior to December 31, 2008 during the period and in accordance with the rules established by the Compensation Committee. No election under this Section 5.2 shall (i) change the payment date of any distribution otherwise scheduled to be paid in 2008 or (ii) cause a payment to be made in 2008 that was otherwise scheduled for payment in a later year.
5.3 Effect of Payment. Payment to the person or trust reasonably and in good faith determined by the Compensation Committee to be the Participant's Beneficiary will completely discharge any obligations the Company may have under the Plan. If a Plan benefit is payable to a minor or a person declared to be incompetent or to a person the Compensation Committee in good faith believes to be incompetent or incapable of handling the disposition of property, the Compensation Committee may direct payment of such Plan benefit to the guardian, legal representative or person having the care and
5
custody of such minor and such decision by the Compensation Committee is binding on all parties. The Compensation Committee may initiate reasonable action to ensure that benefits are properly paid to an appropriate guardian.
The Compensation Committee may require proof of incompetence, minority, incapacity or guardianship as it may deem appropriate prior to distribution of the Plan benefit. Such distribution will completely discharge the Compensation Committee from all liability with respect to such benefit.
5.4 Taxation of Plan Benefits. It is intended that each Participant will be taxed on amounts credited to him or her under the Plan at the time such amounts are received, and the provisions of the Plan will be interpreted consistent with that intention.
5.5 Withholding and Payroll Taxes. Edwards will withhold from payments made hereunder any taxes required to be withheld for the payment of taxes to the Federal, or any state or local government.
5.6 Distribution Due to Unforeseeable Emergency. If a Participant (a) incurs a severe financial hardship as a result of (i) a sudden and unexpected illness or accident involving the Participant or his or her spouse or any dependent (as determined pursuant to Section 152(a) of the Code), (ii) a casualty loss involving the Participant's property or (iii) other similar extraordinary and unforeseeable event beyond the Participant's control and (b) does not have any other resources available, whether through reimbursement or compensation (by insurance or otherwise), liquidation of existing assets (to the extent such liquidation would not itself result in financial hardship) or cessation of deferrals under the Plan, to satisfy such financial emergency, then the Participant may apply to the Compensation Committee for an immediate distribution from the vested portion of his or her Account in an amount necessary to satisfy such financial hardship and the tax liability attributable to such distribution. The Compensation Committee shall have complete discretion to accept or reject the request and shall in no event authorize a distribution in an amount in excess of that reasonably required to meet such financial hardship and the tax liability attributable to that distribution. In the event a Participant receives a distribution under this Section 5.6, all deferrals under the Plan will be suspended for the remainder of the Plan Year. In addition, such Participant shall be precluded from enrolling in the Plan for the entire Plan Year beginning January 1 after the request is approved.
ARTICLE VI
BENEFICIARY DESIGNATION
6.1 Beneficiary Designation. Each Participant has the right to designate one or more persons or trusts as the Participant's Beneficiary, primary as well as secondary, to whom benefits under this Plan will be paid in the event of the Participant's death prior to complete distribution to the Participant of the benefits due under the Plan. Each Beneficiary designation will be in a written form prescribed by the Compensation Committee and will be effective only when filed with the Compensation Committee during the Participant's lifetime.
6.2 Amendments to Beneficiary Designation. Any Beneficiary designation may be changed by a Participant without the consent of any Beneficiary by the filing of a new Beneficiary designation with the Compensation Committee. Filing a Beneficiary designation as to any benefits available under the Plan revokes all prior Beneficiary designations effective as of the date such Beneficiary designation is received by the Compensation Committee. If a Participant's Accounts are community property, any Beneficiary designation will be valid or effective only as permitted under applicable law.
6.3 No Beneficiary Designation. In the absence of an effective Beneficiary designation, or if all Beneficiaries predecease the Participant, the Participant's estate will be the Beneficiary. If a Beneficiary dies after the Participant and before payment of benefits under this Plan has been completed, and no secondary Beneficiary has been designated to receive such Beneficiary's share, the remaining benefits will be payable to the Beneficiary's estate.
6
ARTICLE VII
AMENDMENT AND TERMINATION OF PLAN
7.1 Amendment. The Compensation Committee may, subject to compliance with Code Section 409A and the Treasury Regulations promulgated thereunder, amend the Plan at any time, except that no amendment will decrease or restrict the Accounts of Participants and Beneficiaries at the time of the amendment. Notwithstanding the foregoing, if the Compensation Committee determines that additional restrictions or limitations must be placed on the investment vehicles utilized for measuring the return on the amounts credited to Participant Accounts, the right of Participants to make investment elections with respect to their Accounts, their ability to make or change distribution elections, their ability to defer distributions, the commencement date for the distribution of their benefits and the method of such distribution or their rights or status as creditors under the Plan in order to avoid current income taxation of amounts deferred under the Plan, the Compensation Committee may, in its sole discretion, amend the Plan to impose such restrictions or limitations, cease deferrals under the Plan and/or defer distribution dates under the Plan.
7.2 Right to Terminate. The Compensation Committee may at any time terminate the Plan, subject to compliance with Code Section 409A and the Treasury Regulations promulgated thereunder.
8.1 Unfunded Plan. This Plan is intended to be an unfunded retirement plan maintained primarily to provide retirement benefits for a select group of management or highly compensated employees. All credited amounts are unfunded, general obligations of the Company. The Plan constitutes a mere promise by the Company to make payments in the future in accordance with the terms of the Plan. Participants and Beneficiaries have the status of general unsecured creditors of the Company. Plan benefits will be paid from the general assets of the Company and nothing in the Plan will be construed to give any Participant or any other person rights to any specific assets of the Company, subject to compliance with Section 409A and the Treasury Regulations promulgated thereunder.
8.2 Nonassignability. Neither a Participant nor any other person will have any right to commute, sell, assign, transfer, pledge, anticipate, mortgage or otherwise encumber, transfer, hypothecate or convey in advance of actual receipt the amounts, if any, payable hereunder, or any part thereof, which are, and all rights to which are, expressly declared to be nonassignable and nontransferable. No part of the amounts payable will, prior to actual payment, be subject to seizure or sequestration for the payment of any debts, judgments, alimony or separate maintenance owed by a Participant or any other person, nor be transferable by operation of law in the event of a Participant's or any other person's bankruptcy or insolvency. Nothing contained herein will preclude the Company from offsetting any amount owed to it by a Participant against payments to such Participant or his or her Beneficiary to the extent permitted under Section 409A and the Treasury Regulations promulgated thereunder.
8.3 Claims Procedure If a claim for benefits by a Participant or his or her beneficiary or beneficiaries (the "applicant") is denied, the Compensation Committee will furnish the applicant within 90 days after receipt of such claim (or within 180 days after receipt if the Compensation Committee notifies the applicant prior to the end of the 90 day period that special circumstances require an extension of time), a written notice which specifies the reason for the denial, refers to the pertinent provisions of the Plan on which the denial is based, describes any additional material or information necessary for properly completing the claim and explains why such material or information is necessary, and explains the claim review procedures of this Section 8.3. If, within 60 days after receipt of such notice, the applicant so requests in writing, the Compensation Committee will review its earlier decision. The Compensation Committee's decision on review will be in writing, and will include specific
7
reasons for the decision, written in a manner calculated to be understood by the claimant, and will include specific references to the pertinent provisions of the Plan on which the decision is based. It will be delivered to the claimant within 60 days after the request for review is received, unless extraordinary circumstances require a longer period, but in no event more than 120 days after the request for review is received.
8.4 Indemnification. The Company and its Affiliates will indemnify and hold harmless the Board of Directors, the members of the Compensation Committee and the Administrative Committee, and employees of the Company and the affiliates who may be deemed fiduciaries of the Plan, from and against any and all liabilities, claims, costs and expenses, including attorneys' fees, arising out of an alleged breach in the performance of their fiduciary duties under the Plan, other than such liabilities, claims, costs and expenses as may result from the gross negligence or willful misconduct of such persons. The Company and its affiliates shall have the right, but not the obligation, to conduct the defense of such persons in any proceeding to which this Section 8.4 applies.
8.5 Not a Contract of Employment. The terms and conditions of this Plan will not be deemed to constitute a contract of employment between a Participant and the Company or any affiliates, and neither the Participant nor the Participant's Beneficiary will have any rights against the Company or any affiliate except as may otherwise be specifically provided herein. Moreover, nothing in this Plan is deemed to give a Participant the right to be retained in the service of his or her employer or to interfere with the right of such employer to discipline or discharge him or her at any time.
8.6 Protective Provisions. A Participant will cooperate with the Company by furnishing any and all information requested by the Company, in order to facilitate the payment of benefits hereunder.
8.7 Governing Law. The provisions of this Plan will be construed and interpreted according to the laws of the State of California, to the extent not preempted by ERISA.
8.8 Severability. In the event any provision of the Plan is held invalid or illegal for any reason, any illegality or invalidity will not affect the remaining parts of the Plan, but the Plan will be construed and enforced as if the illegal or invalid provision had never been inserted, and Edwards will have the privilege and opportunity to correct and remedy such questions of illegality or invalidity by amendment as provided in the Plan, including, but not by way of limitation, the opportunity to construe and enforce the Plan as if such illegal and invalid provision had never been inserted herein.
8.9 Successors. The provisions of this Plan will bind and inure to the benefit of the Company, the Participants and Beneficiaries, and their respective successors, heirs and assigns. The term successors as used herein will include any corporate or other business entity which, whether by merger, consolidation, purchase or otherwise acquires all or substantially all of the business and assets of Edwards, and successors of any such corporation or other business entity.
8.10 Effect on Benefit Plans. Amounts paid under this Plan, will not by operation of this Plan be considered to be compensation for the purposes of any benefit plan maintained by the Company or any affiliate. The treatment of such amounts under other employee benefit plans will be determined pursuant to the provisions of such plans.
8.11 Compliance with Code Section 409A. This Plan is intended to comply with the requirements of Code Section 409A. Accordingly, all provisions herein shall be construed and interpreted to comply with Code Section 409A and if necessary, any such provision shall be deemed amended to comply with Code Section 409A and the regulations thereunder.
8
The Company has caused this instrument to be executed by its authorized officer, as of , 2011.
EDWARDS LIFESCIENCES CORPORATION | ||||
By: |
||||
Its: | |
9
EDWARDS LIFESCIENCES CORPORATION
CERTIFICATIONS PURSUANT TO
SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
CERTIFICATION
I, Michael A. Mussallem, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Edwards Lifesciences Corporation;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5. The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Date: November 8, 2011 | By: | /s/ MICHAEL A. MUSSALLEM Michael A. Mussallem Chairman of the Board and Chief Executive Officer |
EDWARDS LIFESCIENCES CORPORATION
CERTIFICATIONS PURSUANT TO
SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
CERTIFICATION
I, Thomas M. Abate, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Edwards Lifesciences Corporation;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c) Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5. The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Date: November 8, 2011 | By: | /s/ THOMAS M. ABATE Thomas M. Abate Corporate Vice President, Chief Financial Officer (Chief Accounting Officer) |
EDWARDS LIFESCIENCES CORPORATION
CERTIFICATION PURSUANT TO
18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO
SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Edwards Lifesciences Corporation (the "Company") on Form 10-Q for the period ended September 30, 2011 as filed with the Securities and Exchange Commission on the date hereof (the "Report"), we, Michael A. Mussallem, Chairman of the Board and Chief Executive Officer of the Company, and Thomas M. Abate, Corporate Vice President, Chief Financial Officer, certify, pursuant to 18 U.S.C. 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
November 8, 2011 | /s/ MICHAEL A. MUSSALLEM Michael A. Mussallem Chairman of the Board and Chief Executive Officer |
|||
November 8, 2011 |
/s/ THOMAS M. ABATE Thomas M. Abate Corporate Vice President, Chief Financial Officer (Chief Accounting Officer) |
EARNINGS PER SHARE (Details) (USD $) In Millions, except Per Share data | 3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2011 | Sep. 30, 2010 | Sep. 30, 2011 | Sep. 30, 2010 | |
Basic: | ||||
Net income | $ 51.6 | $ 48.0 | $ 173.6 | $ 153.2 |
Weighted-average shares outstanding (in shares) | 114.6 | 113.6 | 114.8 | 113.4 |
Basic earnings per share (in dollars per share) | $ 0.45 | $ 0.42 | $ 1.51 | $ 1.35 |
Diluted: | ||||
Net income | $ 51.6 | $ 48.0 | $ 173.6 | $ 153.2 |
Weighted-average shares outstanding (in shares) | 114.6 | 113.6 | 114.8 | 113.4 |
Dilutive effect of stock plans (in shares) | 4.4 | 5.3 | 5.0 | 5.5 |
Dilutive weighted-average shares outstanding (in shares) | 119.0 | 118.9 | 119.8 | 118.9 |
Diluted earnings per share (in dollars per share) | $ 0.43 | $ 0.40 | $ 1.45 | $ 1.29 |
Stock options and restricted stock units not included in computation of diluted earnings per share anti-dilutive effect (in shares) | 1.3 | 1.7 | 0.9 | 1.2 |
CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS (USD $) In Millions, except Per Share data | 3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2011 | Sep. 30, 2010 | Sep. 30, 2011 | Sep. 30, 2010 | |
Net sales | $ 412.7 | $ 348.9 | $ 1,248.4 | $ 1,054.6 |
Cost of goods sold | 125.6 | 95.8 | 370.2 | 294.8 |
Gross profit | 287.1 | 253.1 | 878.2 | 759.8 |
Selling, general and administrative expenses | 165.5 | 133.0 | 479.0 | 407.6 |
Research and development expenses | 61.7 | 52.7 | 185.6 | 148.5 |
Special charges, net (Note 2) | 3.9 | 4.0 | 12.2 | |
Interest expense (income), net | 0.4 | (0.3) | 1.1 | |
Other expense (income), net | 2.3 | (3.1) | (5.1) | (7.7) |
Income before provision for income taxes | 57.6 | 66.2 | 215.0 | 198.1 |
Provision for income taxes | 6.0 | 18.2 | 41.4 | 44.9 |
Net income | $ 51.6 | $ 48.0 | $ 173.6 | $ 153.2 |
Earnings per share: | ||||
Basic (in dollars per share) | $ 0.45 | $ 0.42 | $ 1.51 | $ 1.35 |
Diluted (in dollars per share) | $ 0.43 | $ 0.40 | $ 1.45 | $ 1.29 |
Weighted-average number of common shares outstanding: | ||||
Basic (in shares) | 114.6 | 113.6 | 114.8 | 113.4 |
Diluted (in shares) | 119.0 | 118.9 | 119.8 | 118.9 |
SEGMENT INFORMATION (Details 2) (USD $) In Millions | 3 Months Ended | 9 Months Ended | |||
---|---|---|---|---|---|
Sep. 30, 2011 | Sep. 30, 2010 | Sep. 30, 2011 | Sep. 30, 2010 | Dec. 31, 2010 | |
Enterprise-Wide Information | |||||
Net sales | $ 412.7 | $ 348.9 | $ 1,248.4 | $ 1,054.6 | |
Long-Lived Tangible Assets by Geographic Area | 311.0 | 311.0 | 282.8 | ||
United States | |||||
Enterprise-Wide Information | |||||
Net sales | 150.5 | 140.1 | 450.9 | 423.1 | |
Long-Lived Tangible Assets by Geographic Area | 206.8 | 206.8 | 180.5 | ||
International | |||||
Enterprise-Wide Information | |||||
Net sales | 262.2 | 208.8 | 797.5 | 631.5 | |
Long-Lived Tangible Assets by Geographic Area | 104.2 | 104.2 | 102.3 | ||
Heart Valve Therapy | |||||
Enterprise-Wide Information | |||||
Net sales | 246.1 | 200.6 | 754.1 | 612.1 | |
Critical Care | |||||
Enterprise-Wide Information | |||||
Net sales | 126.7 | 111.0 | 375.0 | 326.6 | |
Cardiac Surgery Systems | |||||
Enterprise-Wide Information | |||||
Net sales | 26.9 | 23.7 | 80.3 | 75.0 | |
Vascular | |||||
Enterprise-Wide Information | |||||
Net sales | $ 13.0 | $ 13.6 | $ 39.0 | $ 40.9 |
INVENTORIES, NET (Tables) | 9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2011 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INVENTORIES, NET | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Inventories, net of reserves |
|
COMMITMENTS AND CONTINGENCIES (Details) (CoreValve, Inc., USD $) In Millions | Apr. 30, 2010 |
---|---|
CoreValve, Inc. | |
LEGAL PROCEEDINGS | |
Amount awarded in damages | $ 73.9 |
INVESTMENTS IN UNCONSOLIDATED AFFILIATES (Tables) | 9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sep. 30, 2011 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
INVESTMENTS IN UNCONSOLIDATED AFFILIATES | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of investments in unconsolidated affiliates |
|
STOCK-BASED COMPENSATION (Details 2) (USD $) | 3 Months Ended | 9 Months Ended | ||
---|---|---|---|---|
Sep. 30, 2011
Y | Sep. 30, 2010
Y | Sep. 30, 2011
Y | Sep. 30, 2010
Y | |
Weighted-average assumptions for options and ESPP subscriptions granted | ||||
Fair value (in dollars per share) | $ 87.83 | |||
Option Awards | ||||
Weighted-average assumptions for options and ESPP subscriptions granted | ||||
Risk-free interest rate (as a percent) | 1.40% | 1.70% | 1.70% | 2.00% |
Expected volatility (as a percent) | 27.20% | 25.70% | 27.30% | 25.90% |
Expected term (in years) | 4.7 | 4.8 | 4.5 | 4.6 |
Fair value (in dollars per share) | $ 21.72 | $ 14.25 | $ 22.81 | $ 12.98 |
ESPP | ||||
Weighted-average assumptions for options and ESPP subscriptions granted | ||||
Risk-free interest rate (as a percent) | 0.10% | 0.30% | 0.20% | 0.30% |
Expected volatility (as a percent) | 29.80% | 24.00% | 27.60% | 27.50% |
Expected term (in years) | 0.6 | 0.6 | 0.6 | 0.6 |
Fair value (in dollars per share) | $ 21.06 | $ 12.61 | $ 20.02 | $ 12.09 |
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FAIR VALUE MEASUREMENTS AND FINANCIAL INSTRUMENTS | 9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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FAIR VALUE MEASUREMENTS AND FINANCIAL INSTRUMENTS |
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FAIR VALUE MEASUREMENTS AND FINANCIAL INSTRUMENTS (Tables) | 9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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FAIR VALUE MEASUREMENTS AND FINANCIAL INSTRUMENTS | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of financial instruments measured at fair value on a recurring basis |
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DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES (Details 2) (Foreign currency contracts, USD $) In Millions | Dec. 31, 2010
Accrued liabilities | Sep. 30, 2011
Prepaid expenses |
---|---|---|
Derivatives designated as hedging instruments | ||
Fair value of derivative liabilities designated as hedging instruments | $ 14.7 | |
Fair value of derivative assets designated as hedging instruments | $ 1.6 |
OTHER INTANGIBLE ASSETS (Details 2) (USD $) In Millions | 3 Months Ended | 9 Months Ended | 12 Months Ended | ||
---|---|---|---|---|---|
Sep. 30, 2011 | Sep. 30, 2010 | Sep. 30, 2011 | Sep. 30, 2010 | Dec. 31, 2010 | |
OTHER INTANGIBLE ASSETS | |||||
Amortization expense related to other intangible assets | $ 2.4 | $ 4.2 | $ 10.8 | $ 12.4 | |
Estimated amortization expense | |||||
2011 | 13.0 | ||||
2012 | 12.1 | ||||
2013 | 12.0 | ||||
2014 | 10.8 | ||||
2015 | $ 9.6 |
OTHER INTANGIBLE ASSETS (Tables) | 9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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OTHER INTANGIBLE ASSETS | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Schedule of other intangible assets |
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Schedule of estimated future amortization expense |
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COMPREHENSIVE INCOME | 9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2011 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
COMPREHENSIVE INCOME | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
COMPREHENSIVE INCOME |
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ACQUISITION | 9 Months Ended | |||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2011 | ||||||||||||||||||||||||||||||||||||||||||
ACQUISITION | ||||||||||||||||||||||||||||||||||||||||||
ACQUISITION |
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INVENTORIES, NET (Details) (USD $) In Millions | Sep. 30, 2011 | Dec. 31, 2010 |
---|---|---|
Inventories, net | ||
Raw materials | $ 47.6 | $ 38.2 |
Work in process | 70.3 | 39.0 |
Finished products | 130.0 | 126.4 |
Total inventories | $ 247.9 | $ 203.6 |
DEFINED BENEFIT PLANS | 9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2011 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DEFINED BENEFIT PLANS | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DEFINED BENEFIT PLANS |
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INCOME TAXES | 9 Months Ended | |
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Sep. 30, 2011 | ||
INCOME TAXES | ||
INCOME TAXES |
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STOCK-BASED COMPENSATION | 9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2011 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
STOCK-BASED COMPENSATION | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
STOCK-BASED COMPENSATION |
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EARNINGS PER SHARE (Tables) | 9 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2011 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
EARNINGS PER SHARE | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Summary of computation of basic and diluted earnings per share |
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DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES | 9 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Sep. 30, 2011 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
DERIVATIVE INSTRUMENTS AND HEDGING ACTIVITIES |
|
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