QuickLinks -- Click here to rapidly navigate through this document

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, 2003

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 of Puerto Rico
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


Edwards Lifesciences Corporation of Puerto Rico
Savings and Investment Plan
Index to Financial Statements and Supplemental Schedule

 
   Page
Reports of Independent Registered Public Accounting Firm   1
Financial Statements:    
  Statements of Net Assets Available for Benefits as of December 31, 2003 and 2002   3
  Statements of Changes in Net Assets Available for Benefits for the years ended December 31, 2003 and 2002   4
  Notes to Financial Statements   5
Supplemental Schedules*    
Signature   10
Exhibits:    
  23.1—Consent of Independent Registered Public Accounting Firm   12
  23.2—Consent of Independent Registered Public Accounting Firm   13

*
Schedules required by Section 2520.103-10 of the Department of Labor Rules and Regulations for Reporting and Disclosure under ERISA have been omitted because they are not applicable.

i


Report of Independent Registered Public Accounting Firm

To the Participants and 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 the Edwards Lifesciences Corporation of Puerto Rico Savings and Investment Plan ("the Plan") as of December 31, 2003, and the related statement of changes in net assets available for benefits for the year ended December 31, 2003. 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 audit in accordance with the 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. 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 audit provides 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 the Plan as of December 31, 2003 and the changes in net assets available for benefits for the year ended December 31, 2003 in conformity with accounting principles generally accepted in the United States of America.

/s/ Moss Adams LLP
Orange County, California

May 28, 2004

1


Report of Independent Registered Public Accounting Firm

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

        In our opinion, the accompanying statement of net assets available for benefits and the related statement of changes in net assets available for benefits present fairly, in all material respects, the net assets available for benefits of the Edwards Lifesciences Corporation of Puerto Rico Savings and Investment Plan (the "Plan") at December 31, 2002, and the changes in net assets available for benefits for the year ended December 31, 2002 in conformity with accounting principles generally accepted in the United States of America. 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 audit. We conducted our audit of these statements in accordance with the 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. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, and evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion.

/s/ PricewaterhouseCoopers LLP
Orange County, California

June 26, 2003

2


Edwards Lifesciences Corporation of Puerto Rico
Savings and Investment Plan
Statements of Net Assets Available for Benefits

 
   December 31,
  
 
   2003
   2002
  
ASSETS              
  Investments in Master Trust, at fair value   $ 7,308,972   $ 5,977,229  
  Dividend and interest receivable     —     1,225  
   
 
 
    Total assets     7,308,972     5,978,454  
   
 
 
LIABILITIES              
  Accounts payable     (43,034 )   (5,914 )
   
 
 
NET ASSETS AVAILABLE FOR BENEFITS   $ 7,265,938   $ 5,972,540  
   
 
 

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

3


Edwards Lifesciences Corporation of Puerto Rico
Savings and Investment Plan
Statements of Changes in Net Assets Available for Benefits

 
   Year Ended December 31,
 
   2003
   2002
Additions to net assets attributed to:            
  Investment income:            
    Net appreciation in fair value of Master Trust   $ 466,938   $ —
    Interest     153,128     270,080
    Dividends     —     1,114
   
 
      Total investment income     620,066     271,194
  Contributions:            
    Participant contributions     863,267     793,360
    Company contributions     400,317     363,711
   
 
      Total contributions     1,263,584     1,157,071
   
 
      Total additions     1,883,650     1,428,265
Deductions from net assets attributed to:            
  Net depreciation in fair value of Master Trust     —     709,452
  Benefits paid to participants     518,385     313,179
  Administrative expenses     71,867     4,742
   
 
    Total deductions     590,252     1,027,373
   
 
Net increase in net assets available for benefits     1,293,398     400,892
Net assets available for benefits:            
  Beginning of year     5,972,540     5,571,648
   
 
  End of year   $ 7,265,938   $ 5,972,540
   
 

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

4


Edwards Lifesciences Corporation of Puerto Rico
Savings and Investment Plan
Notes to Financial Statements

1.    Description of the Plan

        The following description of the Edwards Lifesciences Corporation of Puerto Rico 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 the Company who have met certain eligibility requirements, as described below.

Eligibility

        Employees become eligible to participate in the Plan on the first day of the first calendar quarter following 12 consecutive months of employment and being credited with 1,000 hours of service. Eligible individuals are those who are employed within the Commonwealth of Puerto Rico by the Company, or a subsidiary, division or facility of the Company that has adopted the Plan with the Company's consent, 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 Parent Company and are currently employees of the Parent Company. Banco Popular de Puerto Rico and State Street Bank and Trust Company ("Trustees") serve as trustees of the Plan assets and Watson Wyatt & Company provides record keeping services for the Plan.

Contributions

        The Plan allows tax deferred contributions intended to qualify under the applicable laws of the Commonwealth of Puerto Rico and the United States Internal Revenue Code ("IRC"). Eligible participants may make pre-tax contributions up to 10% of their eligible annual compensation within certain limitations. The Company matches the first six percent of the participant's annual eligible compensation contributed to the Plan at the rate of 50 cents for each contributed dollar.

5


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. On 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:

Participant Loans

        Participants may borrow an amount ranging from a minimum of $1,000 up to a maximum equal to the lesser of $50,000 or 50% of their vested account balances. The loans bear interest based on the applicable prime rate at the time of issuance plus 1%, which interest rates presently range from 5.25% to 10.50%, and have a maximum term of five years (or ten years if used to acquire a home). Upon making a hardship withdrawal, a participant may not make additional pre-tax contributions for a period of 12 months from the date of the withdrawal payment.

6


Payment of Benefits

        On 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 $5,000 or less will be automatically paid in a lump-sum amount.

        A participant may make withdrawals from the participant's accounts (except as provided in the Plan document) upon reaching age 591/2, becoming fully vested and completing 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

        In 2003, substantially all investment manager, trustee and administrative fees incurred in the administration of the Plan were paid from the assets of the Plan. In 2002, certain investment manager, trustee and administrative fees incurred in the administration of the Plan were paid from the assets of the Plan and $99,000 of administrative fees were paid by the Company on behalf of the Plan.

Forfeitures

        A participant's nonvested balance is forfeited at the time of termination of employment. Such forfeitures may be used to offset future Company matching contributions.

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.

Investment Valuation and Income Recognition

        The investment in the Master Trust (see Note 3) is valued at the net asset value of the underlying investments within the Master Trust. The Master Trust's assets are primarily invested in funds managed by State Street Bank and Trust Company 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.

        Investment loss from Master Trust includes realized gains and losses on the sale of investments and unrealized appreciation or depreciation.

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.

7


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.

3.     Investments

        The Master Trust, held by State Street Bank and Trust Company holds the assets of the Plan and the Edwards Lifesciences Corporation 401(k) Savings and Investment Plan.

        The accompanying statements of net assets available for Plan 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 as provided by State Street Bank and Trust Company for the Trust as of December 31 is as follows:

 
   December 31,
  
 
   2003
   2002
  
Cash and cash equivalents   $ 21,550   $ 116,451  
Commingled and common stock funds     140,871,335     115,764,573  
Participant Loans     5,054,897     4,784,465  
   
 
 
  Net assets held by Master Trust   $ 145,947,782   $ 120,665,489  
   
 
 
% of plan net assets held by Master Trust     5 %   5 %
   
 
 

        Investment income (loss) from Master Trust investments for the years ended December 31, 2003, and 2002 is as follows:

 
   Year Ended December 31,
  
 
   2003
   2002
  
Interest income   $ 1,687,510   $ 2,267,952  
Dividend income     152,834     163,292  
Net appreciation (deprecation) in fair value of Commingled and common stock funds     17,891,710     (20,497,989 )
   
 
 
  Plan investment income (loss) from Master Trust   $ 19,732,054   $ (18,066,745 )
   
 
 
% of plan investment income (loss) from Master Trust     3 %   2 %
   
 
 

4.    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.

8


5.    Tax Status of the Plan

        The Company has received a favorable determination letter from the Internal Revenue Service and the Puerto Rico Treasury Department (Departmento de Hacienda) 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 both internal revenue codes.

6.    Related Parties

        At December 31, 2003 and 2002, the Plan, through its investment in the Master Trust, held units of participation in certain commingled funds, which held shares of common stock of the Company, and held short-term investment funds of the Trustee. These transactions are allowable party-in-interest transactions under ERISA and the regulations promulgated thereunder.

9


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 OF PUERTO RICO SAVINGS AND INVESTMENT PLAN

June 24, 2004
By:
/s/  CORINNE H. LYLE      
Corinne H. Lyle
Member of the Administrative and
Investment Committee for the
Edwards Lifesciences Corporation
Employee Benefit Plans

10


EXHIBIT INDEX

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

Exhibit No.
   Description
23.1   Consent of Independent Registered Public Accounting Firm
23.2   Consent of Independent Registered Public Accounting Firm

11



QuickLinks

Edwards Lifesciences Corporation of Puerto Rico Savings and Investment Plan Index to Financial Statements and Supplemental Schedule
Report of Independent Registered Public Accounting Firm
Report of Independent Registered Public Accounting Firm
Edwards Lifesciences Corporation of Puerto Rico Savings and Investment Plan Statements of Net Assets Available for Benefits
Edwards Lifesciences Corporation of Puerto Rico Savings and Investment Plan Statements of Changes in Net Assets Available for Benefits
Edwards Lifesciences Corporation of Puerto Rico Savings and Investment Plan Notes to Financial Statements
SIGNATURE
EXHIBIT INDEX