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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549



FORM 11-K

(Mark One)    

ý

 

ANNUAL REPORT PURSUANT TO SECTION 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2009

OR

o

 

TRANSITION REPORT PURSUANT TO SECTION 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                             to                            

Commission file number 1-15525



A.
Full title of the plan and the address of the plan, if different from that of the issuer named below:


Edwards Lifesciences Corporation
401(k) Savings and Investment Plan

B.
Name of issuer of the securities held pursuant to the plan and the address of its principal executive office:

Edwards Lifesciences Corporation

One Edwards Way
Irvine, California 92614
(949) 250-2500


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Edwards Lifesciences Corporation

401(k) Savings and Investment Plan

Index to Financial Statements and Supplemental Schedule

 
  Page

Report of Independent Registered Public Accounting Firm

  1

Financial Statements:

   
 

Statements of Net Assets Available for Benefits as of December 31, 2009 and 2008

  2
 

Statements of Changes in Net Assets Available for Benefits for the years ended December 31, 2009 and 2008

  3
 

Notes to Financial Statements

  4

Supplemental Schedule

  14

Signature

  15

Exhibits:

   
 

23—Consent of Independent Registered Public Accounting Firm

   

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Report of Independent Registered Public Accounting Firm

To the Administrative and Investment Committee
for the Edwards Lifesciences Corporation Employee Benefit Plans:

        We have audited the accompanying statements of net assets available for benefits of Edwards Lifesciences Corporation 401(k) Savings and Investment Plan (the Plan) as of December 31, 2009 and 2008, and the related statements of changes in net assets available for benefits for the years then ended. These financial statements are the responsibility of the Plan's management. Our responsibility is to express an opinion on these financial statements based on our audits.

        We conducted our audits in accordance with the auditing standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The Plan has determined it is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Plan's internal control over financial reporting. Accordingly, we express no such opinion. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

        In our opinion, the financial statements referred to above present fairly, in all material respects, the net assets available for benefits of Edwards Lifesciences Corporation 401(k) Savings and Investment Plan as of December 31, 2009 and 2008, and the changes in net assets available for benefits for the years then ended, in conformity with U.S. generally accepted accounting principles.

        Our audits were made for the purpose of forming an opinion on the basic financial statements taken as a whole. The supplemental schedule of assets (held at end of year) at December 31, 2009 is presented for the purpose of additional analysis and is not a required part of the basic financial statements, but is supplementary information required by the United States Department of Labor Rules and Regulations for Reporting and Disclosure under the Employee Retirement Income Security Act of 1974. This supplemental schedule is the responsibility of the Plan's management. The supplemental schedule has been subjected to the auditing procedures applied in the audits of the basic financial statements and, in our opinion, is fairly stated in all material respects in relation to the basic financial statements taken as a whole.

/s/ HEIN & ASSOCIATES LLP

Irvine, California
       

June 24, 2010

 

 

 

 

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Edwards Lifesciences Corporation

401(k) Savings and Investment Plan

Statements of Net Assets Available for Benefits

 
  December 31,  
 
  2009   2008  

Investments in Master Trust, at fair value

  $ 243,813,206   $ 182,195,326  

Participant loans receivable

    5,895,025     5,104,082  

Dividends and interest receivable

    36,916     36,925  

Company contributions receivable

    137,651     137,654  
           

Net assets available for benefits at fair value

    249,882,798     187,473,987  

Adjustment from fair value to contract value for investment in Master Trust from fully benefit-responsive investment contracts (Note 2)

    (1,195,813 )   568,189  
           

NET ASSETS AVAILABLE FOR BENEFITS

  $ 248,686,985   $ 188,042,176  
           

The accompanying notes are an integral part of these financial statements.

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Edwards Lifesciences Corporation

401(k) Savings and Investment Plan

Statements of Changes in Net Assets Available for Benefits

 
  Years Ended December 31,  
 
  2009   2008  

Additions to net assets attributed to:

             
 

Investment income (loss):

             
   

Net appreciation (depreciation) in fair value of Master Trust

  $ 41,237,114   $ (38,259,560 )
   

Interest

    2,143,187     2,137,992  
   

Dividends

    1,215,127     1,707,687  
   

Participant loans interest

    354,582     376,434  
           
     

Total investment income (loss)

    44,950,010     (34,037,447 )
           
 

Contributions:

             
   

Participant contributions

    15,233,617     13,505,046  
   

Company contributions

    6,894,651     5,567,040  
   

Rollover contributions

    1,357,840     1,626,599  
           
     

Total contributions

    23,486,108     20,698,685  
           
       

Total additions (reductions)

    68,436,118     (13,338,762 )
           

Deductions from net assets attributed to:

             
 

Benefits paid to participants

    7,714,580     12,458,757  
 

Administrative expenses

    76,729     84,642  
           
   

Total deductions

    7,791,309     12,543,399  
           

Net increase (decrease) in net assets available for benefits

    60,644,809     (25,882,161 )

Net assets available for benefits:

             
 

Beginning of year

    188,042,176     213,924,337  
           
 

End of year

  $ 248,686,985   $ 188,042,176  
           

The accompanying notes are an integral part of these financial statements.

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Edwards Lifesciences Corporation

401(k) Savings and Investment Plan

Notes to Financial Statements

1.     Description of the Plan

        The following description of the Edwards Lifesciences Corporation 401(k) Savings and Investment Plan (the "Plan") is provided for general information purposes only. Participants should refer to the Plan document for more complete information.

General

        The Plan is a defined contribution retirement plan subject to the provisions of the Employee Retirement Income Security Act of 1974, as amended ("ERISA"). Participation in the Plan is available to employees of Edwards Lifesciences Corporation (the "Company") who have met certain eligibility requirements, as described below.

Eligibility

        Employees become eligible to participate in the Plan on the thirty-first day after an employee is credited with an hour of service. Eligible individuals are those who are U.S. employees of the Company, or a subsidiary, division or facility of the Company that has adopted the Plan, other than:

Plan Administration

        The Plan is administered by the Administrative and Investment Committee for the Edwards Lifesciences Corporation Employee Benefit Plans (the "Committee"). The Committee has authority, responsibility and control over the management of the assets of the Plan. Members of the Committee are appointed by the Board of Directors of the Company and are employees of the Company. State Street Bank and Trust Company ("Trustee") serves as trustee of the Plan's assets and ING Group provides record keeping services for the Plan.

Contributions

        The Plan allows tax deferred contributions intended to qualify under Section 401(k) of the Internal Revenue Code ("IRC"). Eligible participants may make pre-tax contributions up to 25% of their eligible annual compensation within certain limitations. The Company matches the first three percent of the participant's annual eligible compensation contributed to the Plan on a dollar for dollar basis. The Company matches the next two percent of the participant's annual eligible compensation to the Plan on a 50% basis. In addition, if a participant is age 50 or older, the participant is allowed to make additional catch-up contributions within certain limitations. Certain employees are also eligible for

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transitional contributions related to the spin-off from Baxter International, as described more fully in the Plan document.

Participant Accounts

        Each participant's account is credited with the participant's contributions, the Company's matching contributions and the allocation of the participant's share of the Plan's net earnings and losses, net of certain investment management fees. Allocations are based on participant account balances, as defined.

Vesting

        Participants are immediately fully vested in their plan accounts (other than their Company matching contributions) plus actual earnings thereon. Vesting in a participant's Company matching contributions plus actual earnings thereon is based on years of continuous service. A participant vests in Company matching contributions in annual increments of 20% and, therefore, is 100% vested after five years of credited service. Upon termination of service due to death, disability, or attainment of normal retirement age, a participant shall become fully vested.

Investment Options

        Upon enrollment in the Plan, a participant may direct contributions in any of the following investment options within the Master Trust:

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Participant Loans

        Participants may borrow an amount ranging from a minimum of $500 up to a maximum equal to the lesser of $50,000 or 50% of their vested account balances. The loan bears interest based on the applicable prime rate at the time of issuance plus 1%, which interest rates presently range from 4.0% to 9.0%, and has a maximum term of five years (or ten years if used to acquire a home). The loans are collateralized by the participants' vested interest in their accounts and any additional collateral as the Committee may require. Principal and interest are generally paid ratably through payroll deductions.

Payment of Benefits

        Upon termination of service or otherwise becoming eligible to receive benefits, a participant may elect to receive a lump-sum amount equal to the value of the participant's account, receive periodic installments or transfer the balance in the participant's account to another qualified plan. Vested accounts of $1,000 or less will be automatically paid in a lump-sum amount. Vested accounts between $1,000 and $5,000 will be automatically distributed into an individual retirement account designated by the Committee if the participant does not elect to have such distribution paid directly to an eligible retirement plan specified by the participant or to receive the distribution directly in accordance with the Plan.

        A participant may make withdrawals from the participant's accounts (except as provided in the Plan document) if the participant is over age 59 1/2, fully vested and has completed five years of Plan participation. Withdrawals may also be made for financial hardship, which is determined pursuant to the provisions of the IRC. Upon making a hardship withdrawal, a participant may not make additional pre-tax contributions for a period of 6 months from the date of the withdrawal payment.

Administrative Expenses

        Substantially all investment manager, trustee and administrative fees incurred in the administration of the Plan were paid from the assets of the Plan.

Forfeitures

        A participant's non-vested balance is forfeited at the time of termination of employment. Such forfeitures may be used to offset future Company matching contributions. Forfeitures of $582,072 and $938,780 were used to reduce Company matching contributions during 2009 and 2008, respectively. Forfeitures outstanding were approximately $31,773 and $486,702 at December 31, 2009 and 2008, respectively.

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2.     Summary of Significant Accounting Policies

Basis of Accounting

        The accompanying financial statements of the Plan have been prepared on the accrual basis of accounting in conformity with accounting principles generally accepted in the United States of America.

Recently Adopted Accounting Standards

        In April 2009, the Financial Accounting Standards Board ("FASB") issued accounting guidance on estimating fair value when the volume and level of activity for the asset or liability have significantly decreased, and identifying circumstances that indicate a transaction is not orderly. The guidance was effective for interim and annual reporting periods ending after June 15, 2009. The adoption of this guidance did not have a material impact on the Plan's financial statements.

        In May 2009, the FASB issued accounting guidance that established general standards of accounting for and disclosure of events that occur after the balance sheet date but before financial statements are issued or are available to be issued. The guidance required the disclosure of the date through which an entity has evaluated subsequent events and whether that date represents the date the financial statements were issued or were available to be issued. The guidance was effective for interim or annual financial periods ending after June 15, 2009. In February 2010, the FASB issued an amendment to Accounting Standards Codification ("ASC") Topic 855, "Subsequent Events," to remove the requirement for Securities and Exchange Commission ("SEC") filers to disclose the date through which an entity has evaluated subsequent events. This change alleviates potential conflicts with current SEC guidance. The guidance was effective upon its issuance. The adoption of this guidance did not have a material impact on the Plan's financial statements.

        In June 2009, the FASB issued an accounting standard establishing the ASC as the source of authoritative accounting principles recognized by the FASB to be applied by nongovernmental entities in preparation of financial statements in conformity with Generally Accepted Accounting Principles in the United States ("GAAP"). Rules and interpretive releases of the SEC under authority of federal securities laws are also sources of authoritative GAAP for SEC registrants. The accounting standard was effective for financial statements issued for interim and annual periods ending after September 15, 2009. The ASC does not change GAAP and did not have a material impact on the Plan's financial statements.

        In September 2009, the FASB issued an amendment to ASC Topic 820, "Fair Value Measurements and Disclosures," for the fair value measurement of investments in certain entities that calculate net asset value per share (or its equivalent). This update created a practical expedient to measure the fair value of such investments on the basis of the net asset value per share (or its equivalent) and required disclosures by major category of the investments about the attributes of investments, such as the nature of any restrictions on the investor's ability to redeem its investments at the measurement date, any unfunded commitments, and the investment strategies of the investees. The adoption of this guidance did not have a material impact on the Plan's financial statements.

New Accounting Standards Not Yet Adopted

        In January 2010, the FASB issued an amendment to ASC Topic 820, "Fair Value Measurements and Disclosures," to require companies to (a) disclose separately the amounts of significant transfers in and out of Level 1 and Level 2 fair value measurements and describe the reasons for such transfers and (b) present separately in the Level 3 reconciliation information about purchases, sales, issuances and settlements. The amendment also clarifies existing guidance on the level of disaggregation to present and disclosures about inputs and valuation techniques. The guidance is effective for interim and annual reporting periods beginning after December 15, 2009, except for the disclosures about purchases, sales,

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issuances and settlements in the Level 3 reconciliation, which is effective for fiscal years beginning after December 15, 2010, and for interim periods within those years. The Company does not expect the adoption of this guidance will have a material impact on the Plan's financial statements.

Investment Valuation and Income Recognition

        The investment in the Master Trust (see Note 4) is valued at the net asset value ("NAV") of the underlying investments within the Master Trust. The Master Trust's assets are primarily invested in funds managed by the Trustee through a commingled employee benefit funds trust. Units have been purchased in funds which invest primarily in securities of major U.S. companies, international equity securities in both developed and emerging markets, and government agency fixed income securities.

        Purchases and sales of securities are recorded by the Master Trust on a trade-date basis. Realized gains and losses for security transactions are reported using the average cost method. Net appreciation in the Master Trust includes realized gains and losses on the sale of investments and unrealized appreciation or depreciation. Interest income is recorded as earned on an accrual basis, and dividends are recorded on the ex-dividend date.

        The Plan invests in investment contracts through participation in the SSgA Stable Value Par Fund ("Stable Value Fund"), a common collective trust fund. The accounting guidance requires that investment contracts held by a defined contribution plan be reported at fair value. However, contract value is the relevant measurement criteria for that portion of the net assets available for benefits of a defined contribution plan attributable to fully benefit-responsive investment contracts because contract value is the amount participants would receive if they were to initiate permitted transactions under the terms of the Plan. Accordingly, the Statements of Net Assets Available for Benefits reflect these investments at fair value, with a corresponding adjustment to reflect the investments at contract value. The Statements of Changes in Net Assets Available for Benefits are prepared on a contract value basis.

Payment of Benefits

        Benefits to participants are recorded when paid.

Use of Estimates

        The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the financial statements and related notes to the financial statements. Changes in such estimates may affect amounts reported in future periods.

Risks and Uncertainties

        The Plan provides for various investment options in any combination of investment securities. Investment securities are exposed to various risks, such as interest rate, market and credit. Due to the level of risk associated with certain investment securities and the level of uncertainty related to changes in the value of investment securities, it is at least reasonably possible that changes in risks in the near term would materially affect participants' account balances and the amounts reported in the Statements of Net Assets Available for Benefits and the Statements of Changes in Net Assets Available for Benefits.

        The Plan's Stable Value Fund, a common collective trust fund, invests in a variety of investment contracts such as guaranteed investment contracts, bank investment contracts, and/or a wrapped portfolio of fixed income instruments. Participants may ordinarily direct the withdrawal or transfer of all or a portion of their investment in the Stable Value Fund at contract value. Certain events may limit

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the ability of the Plan to transact at contract value with the issuer. The Plan administrator does not believe that the occurrence of any such event is probable.

3.     Fair Value Measurements

        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:

        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.

        The following table summarizes the Plan's financial instruments which are measured at fair value on a recurring basis as of December 31, 2009 and 2008:

December 31, 2009
  Level 1   Level 2   Level 3   Total  

Assets

                         

Mutual funds

  $ 62,751,217   $   $   $ 62,751,217  

Common stock

    56,639,537             56,639,537  

Common/collective trust funds

        122,257,152         122,257,152  

Money market funds

        2,165,300         2,165,300  

Participant loans

            5,895,025     5,895,025  
                   

  $ 119,390,754   $ 124,422,452   $ 5,895,025   $ 249,708,231  
                   

 

December 31, 2008
  Level 1   Level 2   Level 3   Total  

Assets

                         

Mutual funds

  $ 40,258,081   $   $   $ 40,258,081  

Common stock

    40,208,098             40,208,098  

Common/collective trust funds

        100,192,214         100,192,214  

Money market funds

        1,536,933         1,536,933  

Participant loans

            5,104,082     5,104,082  
                   

  $ 80,466,179   $ 101,729,147   $ 5,104,082   $ 187,299,408  
                   

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        The following table summarizes the changes in fair value of the Plan's financial assets that have been classified as Level 3 for the years ended December 31, 2009 and 2008:

 
  Participant loans  

Balance at December 31, 2007

  $ 4,639,409  
 

Total gains—realized and unrealized:

       
   

Included in earnings(a)

    376,434  
 

Purchases, sales, issuances, and settlements

    88,239  
       

Balance at December 31, 2008

    5,104,082  
 

Total gains—realized and unrealized:

       
   

Included in earnings(a)

    354,582  
 

Purchases, sales, issuances, and settlements

    436,361  
       

Balance at December 31, 2009

  $ 5,895,025  
       

(a)
Recorded as "Participant loans interest" in the Statements of Changes in Net Assets Available for Benefits.

        Mutual funds and common stock investments are valued at fair value based on quoted market prices reported on the active markets on which the individual securities are traded. Common/collective trust funds and money market funds are valued using the NAV provided by the administrator of the fund. The NAV is based on the fair value of the underlying assets owned by the fund, minus its liabilities, and then divided by the number of shares outstanding. The NAV is classified within Level 2 of the fair value hierarchy as the unit price is not quoted in an active market. However, the unit price is based on underlying investments which are either traded on an active market or are valued based on observable inputs such as market interest rates and quoted prices for similar securities. Participant loans are valued at their outstanding principal balance plus accrued interest, which approximates fair value.

4.     Investments

        The Master Trust, held by State Street Bank and Trust Company, holds the assets of the Plan and the Edwards Lifesciences Technology SARL Savings and Investment Plan.

        The accompanying Statements of Net Assets Available for Benefits reflect the apportioned share of the underlying Plan assets and liabilities of the Trust. Allocations of net income from the Trust are based on the Plan's net assets at the beginning of the year with adjustments for contributions and benefit payments made during the year.

        Summarized financial information for the Trust as of December 31 is as follows:

 
  December 31,  
 
  2009   2008  

Net assets held by Master Trust, at fair value:

             
 

Common/collective trust funds

  $ 134,550,319   $ 110,829,614  
 

Mutual funds

    64,478,136     41,749,586  
 

Common stock funds

    62,097,125     43,450,922  
 

Adjustment from fair value to contract value for fully benefit- responsive investment contracts

    (1,361,529 )   648,831  
           

Net assets available for benefits

  $ 259,764,051   $ 196,678,953  
           

% of Plan net assets held by Master Trust

    93.40 %   92.92 %
           

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        Investment income (loss) from Master Trust investments for the years ended December 31, 2009 and 2008 is as follows:

 
  Years Ended December 31,  
 
  2009   2008  

Interest income

  $ 2,441,516   $ 2,456,760  

Dividend income

    1,240,810     1,747,156  

Net appreciation (depreciation) in fair value:

             
 

Common stock funds

    20,985,197     3,733,104  
 

Mutual funds

    11,580,755     (20,196,700 )
 

Common/collective trust funds

    10,679,727     (23,032,484 )
           

Investment income (loss)

  $ 46,928,005   $ (35,292,164 )
           

% of Plan investment income (loss) from Master Trust

    95.03 %   97.51 %
           

        The only investment that represents 5% or more of the Plan's net assets available for benefits at December 31, 2009 and 2008 was the Plan's interest in the Master Trust.

5.     Distribution Priorities upon Termination of the Plan

        Although it has not expressed any intent to do so, the Company has the right under the Plan to reduce, suspend or discontinue its contributions at any time and to terminate the Plan subject to the provisions of ERISA. Upon termination of the Plan, the account balance of each participant will become 100% vested and all assets, net of expenses, will be distributed to the participants or the participants' beneficiaries.

6.     Tax Status of the Plan

        The Company has received a favorable determination letter from the Internal Revenue Service on the Plan's federal income tax status. Although the Plan has since been amended, the Plan Administrator believes the Plan is currently designed and is being operated in compliance with the applicable requirements of the IRC.

7.     Related Parties

        At December 31, 2009 and 2008, the Plan, through its investment in the Master Trust, held units of participation in certain commingled funds and short-term investment funds of the Trustee and held shares of common stock of the Company. These transactions are allowable party-in-interest transactions under ERISA and the regulations promulgated thereunder.

8.     Reconciliation of Financial Statements to Form 5500

        The following is a reconciliation of amounts reported in the financial statements to amounts reported on Form 5500 as of and for the years ended December 31, 2009 and 2008:

 
  2009   2008  

Statement of Net Assets Available for Benefits:

             

Net assets available for benefits per the financial statements

  $ 248,686,985   $ 188,042,176  

Adjustment from contract value to fair value for fully benefit-responsive investment contracts

    1,195,813     (568,189 )
           

Net assets available for benefits per Form 5500

  $ 249,882,798   $ 187,473,987  
           

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  2009   2008  

Statement of Changes in Net Assets Available for Benefits:

             

Net increase (decrease) in net assets available for benefits per the financial statements

  $ 60,644,809   $ (25,882,161 )

Prior year adjustment from contract value to fair value for fully benefit-responsive investment contracts

    568,189     933,271  

Current year adjustment from contract value to fair value for fully benefit-responsive investment contracts

    1,195,813     (568,189 )

Net asset conversions and other

    (22,589 )   (26,941 )
           

Net income (loss) per Form 5500

  $ 62,386,222   $ (25,544,020 )
           

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Edwards Lifesciences Corporation
401(k) Savings and Investment Plan
Schedule H—line 4i—Schedule of Assets (Held at End of Year)
As of December 31, 2009

(a)
  (b) Identity of issue,
borrower, lessor
or similar party
  (c) Description of investment including maturity date, rate
of interest, collateral, par or maturity value
  (d) Cost
**
  (e) Current
value
 

*

  Participant Loans  

Varying maturity dates with interest rates ranging from 4.0% to 9.0%

      $ 5,895,025  

 

Edwards Lifesciences Corporation 401(k) Savings and Investment Trust

 

Master Trust—Commingled and Common Stock Funds

   
   
242,617,393
 

*
Party-in-interest for which a statutory exemption exists.

**
Cost information is not required for participant-directed investments and therefore has not been included in this schedule.

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SIGNATURE

        The Plan.    Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the administrator of the Plan has duly caused this annual report to be signed on its behalf by the undersigned hereunto duly authorized.

    EDWARDS LIFESCIENCES CORPORATION
401(K) SAVINGS AND INVESTMENT PLAN

June 24, 2010

 

By:

 

/s/ ROBERT C. REINDL

Robert C. Reindl
Member of the Administrative and
Investment Committee for the
Edwards Lifesciences Corporation
Employee Benefit Plans

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EXHIBIT INDEX

        Exhibits are identified below. Exhibit 23 is filed herein as an exhibit hereto.

Exhibit No.   Description

23

 

Consent of Independent Registered Public Accounting Firm—Hein & Associates LLP