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


FORM 10-Q


ý

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended June 30, 2002

o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from                              to                             

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     X                  No         

        The number of shares of the registrant's common stock, par value $1.00 per share, outstanding as of July 31, 2002, the latest practicable date, was 59,837,430 shares.




EDWARDS LIFESCIENCES CORPORATION

FORM 10-Q
For the quarterly period ended June 30, 2002


TABLE OF CONTENTS

 
   
  Page Number
Part I. FINANCIAL INFORMATION    

Item 1.

 

Financial Statements (Unaudited)

 

 

 

 

        Consolidated Condensed Balance Sheets

 

1

 

 

        Consolidated Condensed Statements of Operations

 

2

 

 

        Consolidated Condensed Statements of Cash Flows

 

3

 

 

        Notes to Consolidated Condensed Financial Statements

 

4

Item 2.

 

Management's Discussion and Analysis of Financial Condition and Results of Operations

 

9

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

 

15

Part II. OTHER INFORMATION

 

 

Item 1.

 

Legal Proceedings

 

17

Item 4.

 

Submission of Matters to a Vote of Security Holders

 

18

Item 6.

 

Exhibits and Reports on Form 8-K

 

18

Signature

 

19

Exhibits

 

20


Part I. Financial Information

Item 1. Financial Statements


EDWARDS LIFESCIENCES CORPORATION

CONSOLIDATED CONDENSED BALANCE SHEETS

(unaudited) (in millions, except share data)

 
  June 30, 2002
  December 31, 2001
 
ASSETS  

Current assets

 

 

 

 

 

 

 
  Cash and cash equivalents   $ 35.5   $ 47.7  
  Accounts and other receivables, net     114.4     101.5  
  Inventories     89.4     86.6  
  Deferred income taxes     25.4     18.2  
  Prepaid expenses and other current assets     47.0     38.9  
   
 
 
    Total current assets     311.7     292.9  
Property, plant and equipment, net     178.0     178.3  
Investments in unconsolidated affiliates     90.4     92.9  
Goodwill     333.8     333.8  
Other intangible assets, net     63.2     68.4  
Other assets     6.2     7.1  
   
 
 
    $ 983.3   $ 973.4  
   
 
 

LIABILITIES AND STOCKHOLDERS' EQUITY

 

Current liabilities

 

 

 

 

 

 

 
  Accounts payable and accrued liabilities   $ 185.5   $ 181.5  
  Short-term debt     0.6     1.1  
   
 
 
    Total current liabilities     186.1     182.6  
   
 
 
Long-term debt     296.9     309.8  
Other liabilities     20.7     22.3  
Commitments and contingent liabilities              

Stockholders' equity

 

 

 

 

 

 

 
  Common stock, $1.00 par value, 350,000,000 shares authorized, 59,797,214 and 59,327,872 shares outstanding     59.8     59.3  
  Additional contributed capital     294.9     287.2  
  Retained earnings     139.1     87.7  
  Accumulated other comprehensive income     6.8     25.2  
  Common stock in treasury, at cost     (21.0 )   (0.7 )
   
 
 
    Total stockholders' equity     479.6     458.7  
   
 
 
    $ 983.3   $ 973.4  
   
 
 

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

1



EDWARDS LIFESCIENCES CORPORATION

CONSOLIDATED CONDENSED STATEMENTS OF OPERATIONS

(unaudited) (in millions, except per share information)

 
  Three Months
Ended June 30,

  Six Months
Ended June 30,

 
 
  2002
  2001
  2002
  2001
 
Net sales   $ 172.8   $ 192.4   $ 335.1   $ 384.3  
  Cost of goods sold     74.4     95.2     143.5     191.4  
   
 
 
 
 
Gross profit     98.4     97.2     191.6     192.9  
  Selling, general and administrative expenses     54.3     52.7     105.0     106.5  
  Research and development expenses     16.6     13.5     32.0     26.6  
  Goodwill amortization         5.7         11.4  
  Disposition of assets and other non-recurring charges         83.0         83.0  
  Other operating income     (3.6 )   (4.4 )   (7.4 )   (8.3 )
   
 
 
 
 
Operating income (loss)     31.1     (53.3 )   62.0     (26.3 )
  Interest expense, net     3.0     10.9     5.8     16.4  
  Other (income) expense, net     (15.7 )   7.5     (15.7 )   9.0  
   
 
 
 
 
Income (loss) before provision for income taxes     43.8     (71.7 )   71.9     (51.7 )
  Provision (benefit) for income taxes     13.2     (16.0 )   20.5     (10.2 )
   
 
 
 
 
Income (loss) before cumulative effect of change in accounting principle     30.6     (55.7 )   51.4     (41.5 )
  Cumulative effect of change in accounting principle, net of tax                 (1.5 )
   
 
 
 
 
Net income (loss)   $ 30.6   $ (55.7 ) $ 51.4   $ (43.0 )
   
 
 
 
 
Share information:                          
  Earnings per basic share                          
    Income (loss) before cumulative effect of change in accounting principle   $ 0.52   $ (0.95 ) $ 0.87   $ (0.71 )
    Cumulative effect of change in accounting principle   $   $   $   $ (0.03 )
    Net income (loss)   $ 0.52   $ (0.95 ) $ 0.87   $ (0.73 )
  Earnings per diluted share                          
    Income (loss) before cumulative effect of change in accounting principle   $ 0.50   $ (0.95 ) $ 0.83   $ (0.71 )
    Cumulative effect of change in accounting principle   $   $   $   $ (0.03 )
    Net income (loss)   $ 0.50   $ (0.95 ) $ 0.83   $ (0.73 )
  Weighted average number of common shares outstanding                          
    Basic     59.3     58.8     59.3     58.8  
    Diluted     61.5     58.8     61.7     58.8  

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

2



EDWARDS LIFESCIENCES CORPORATION

CONSOLIDATED CONDENSED STATEMENTS OF CASH FLOWS

(unaudited) (in millions)

 
  Six Months Ended June 30,
 
 
  2002
  2001
 
Cash flows from operating activities              
  Net income (loss)   $ 51.4   $ (43.0 )
  Adjustments              
    Disposition and write-down of assets and other non-recurring charges         89.4  
    Depreciation and amortization     19.3     33.3  
    Cumulative effect of change in accounting principle         1.5  
    Deferred income taxes     (1.1 )   (9.5 )
    Other     3.6     (6.0 )
  Changes in operating assets and liabilities              
    Accounts and other receivables     (15.7 )   (0.1 )
    Inventories     (1.6 )   0.4  
    Accounts payable and accrued liabilities     (4.6 )   (36.8 )
    Other     (8.6 )   (1.5 )
   
 
 
  Net cash provided by operating activities     42.7     27.7  
   
 
 

Cash flows from investing activities

 

 

 

 

 

 

 
  Proceeds from sale of business         45.0  
  Capital expenditures     (16.4 )   (18.8 )
  Proceeds from asset dispositions     2.9     4.9  
  Investments in intangible assets     (2.9 )   (1.7 )
  Investments in unconsolidated affiliates     (1.8 )   (6.7 )
   
 
 
    Net cash (used in) provided by investing activities     (18.2 )   22.7  
   
 
 

Cash flows from financing activities

 

 

 

 

 

 

 
  Proceeds from issuance of short-term debt     0.4     25.0  
  Payments on short-term debt     (0.8 )   (36.9 )
  Proceeds from issuance of long-term debt     46.9     127.3  
  Payments on long-term debt     (71.9 )   (135.4 )
  Proceeds from stock plans     7.4     3.6  
  Purchases of treasury stock     (20.3 )    
  Net proceeds from accounts receivable securitization         0.7  
  Debt issuance costs     (0.3 )   (1.1 )
   
 
 
    Net cash used in financing activities     (38.6 )   (16.8 )
   
 
 
    Effect of currency exchange rate changes on cash     1.9     (0.1 )
   
 
 
Net (decrease) increase in cash and cash equivalents     (12.2 )   33.5  
Cash and cash equivalents at beginning of period     47.7     28.1  
   
 
 
Cash and cash equivalents at end of period   $ 35.5   $ 61.6  
   
 
 

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

3



Edwards Lifesciences

Notes to Consolidated Condensed Financial Statements

June 30, 2002

(unaudited)

1. DESCRIPTION OF BUSINESS

        Edwards Lifesciences Corporation ("Edwards Lifesciences" or the "Company") is a global provider of products and technologies that are designed to treat advanced cardiovascular disease. Edwards Lifesciences' sales are categorized in four main product areas: cardiac surgery, critical care, vascular and perfusion. Edwards Lifesciences' cardiac surgery portfolio is comprised of products relating to heart valve therapy and other products used during open-heart surgery. In the critical care area, Edwards Lifesciences is a world leader in hemodynamic monitoring systems that are used to measure a patient's heart function, and also provides central venous access products for fluid and drug delivery. Edwards Lifesciences' vascular portfolio includes a line of balloon catheter-based products, surgical clips and inserts, angioscopy equipment, and artificial implantable grafts, as well as an endovascular system used to treat life-threatening abdominal aortic aneurysms less invasively. In the perfusion category, Edwards Lifesciences designs, develops, manufactures and markets in regions outside of the United States and Western Europe a diverse line of disposable products used during cardiopulmonary bypass procedures, including oxygenators, blood containers, filters and related devices. Effective June 30, 2001, the Company sold its perfusion services business in the United States to an affiliate of Fresenius Medical Care AG. The Company continues to maintain its perfusion services business in Europe.

2. FINANCIAL INFORMATION

        These interim consolidated condensed financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission and should be read in conjunction with the consolidated financial statements and notes included in the Company's Form 10-K for the year ended December 31, 2001. Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted. Certain reclassifications of previously reported amounts have been made to conform to classifications used in the current period.

        In the opinion of management, the interim consolidated condensed financial statements reflect all adjustments considered necessary for a fair presentation 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.

3. INVENTORIES

        Inventories consisted of the following (in millions):

 
  June 30, 2002
  December 31, 2001
Raw materials   $ 23.4   $ 21.8
Work in process     21.9     23.6
Finished products     44.1     41.2
   
 
    $ 89.4   $ 86.6
   
 

4


4. COMPREHENSIVE INCOME

        Reconciliation of net income to comprehensive income is as follows (in millions):

 
  Three Months Ended June 30,
  Six Months Ended June 30,
 
 
  2002
  2001
  2002
  2001
 
Net income (loss)   $ 30.6   $ (55.7 ) $ 51.4   $ (43.0 )
Other comprehensive income:                          
  Currency translation adjustments, net of tax     (11.2 )   (1.3 )   (6.4 )   19.6  
  Unrealized net (loss) gain on investments in unconsolidated affiliates, net of tax     (2.4 )   2.6     (1.7 )   (1.7 )
  Unrealized net (loss) gain on derivative financial instruments, net of tax     (9.8 )   3.7     (10.3 )   0.9  
   
 
 
 
 
Comprehensive income (loss)   $ 7.2   $ (50.7 ) $ 33.0   $ (24.2 )
   
 
 
 
 

5. GOODWILL AND OTHER INTANGIBLE ASSETS

        On January 1, 2002, the Company adopted Statement of Financial Accounting Standards (SFAS) No. 142, "Goodwill and Other Intangible Assets," whereby goodwill is no longer amortized, but instead is subject to a periodic impairment review. As the Company's operations are comprised of one reporting unit, the Company reviews the recoverability of its goodwill by comparing the Company's fair value to the net book value of its assets. If the book value of the Company's assets exceeds the Company's fair value, the goodwill is written down to its implied fair value.

        Pursuant to SFAS No. 142, the results for periods prior to adoption are not to be restated. If SFAS No. 142 had been effective January 1, 2001, net loss and earnings per basic and diluted share would have been as follows (in millions, except per share information):

 
  Three Months Ended June 30, 2001
  Six Months Ended June 30, 2001
 
Reported net loss   $ (55.7 ) $ (43.0 )
  Goodwill amortization, net of tax     5.6     10.9  
   
 
 
Adjusted net loss   $ (50.1 ) $ (32.1 )
   
 
 

Earnings per basic and diluted share:

 

 

 

 

 

 

 
  Reported net loss   $ (0.95 ) $ (0.73 )
  Adjusted net loss   $ (0.85 ) $ (0.55 )

5


        Other intangible assets subject to amortization consisted of the following (in millions):

June 30, 2002

  Patents
  Unpatented Technology
  Other
  Total
 
Cost   $ 127.3   $ 39.8   $ 5.5   $ 172.6  
Accumulated amortization     (87.8 )   (17.6 )   (4.0 )   (109.4 )
   
 
 
 
 
  Net carrying value   $ 39.5   $ 22.2   $ 1.5   $ 63.2  
   
 
 
 
 

December 31, 2001


 

Patents


 

Unpatented Technology


 

Other


 

Total


 
Cost   $ 128.8   $ 39.8   $ 4.9   $ 173.5  
Accumulated amortization     (84.9 )   (16.4 )   (3.8 )   (105.1 )
   
 
 
 
 
  Net carrying value   $ 43.9   $ 23.4   $ 1.1   $ 68.4  
   
 
 
 
 

        Amortization expense related to other intangible assets for the six months ended June 30, 2002 was $4.4 million. Estimated amortization expense for each of the years ending December 31 is as follows (in millions):

2002   $ 8.2
2003     7.6
2004     7.6
2005     7.6
2006     7.4

6. EARNINGS PER SHARE

        A reconciliation of the shares used in the basic and diluted per share computations is as follows (in millions):

 
  Three Months
Ended
June 30,

  Six Months
Ended
June 30,

 
  2002
  2001
  2002
  2001
Basic shares outstanding   59.3   58.8   59.3   58.8
  Dilutive effect of employee stock purchase plans   0.1      
  Dilutive effect of employee stock options   2.1     2.4  
   
 
 
 
Diluted shares outstanding   61.5   58.8   61.7   58.8
   
 
 
 

6


7. COMMITMENTS AND CONTINGENCIES

        On June 29, 2000, Edwards Lifesciences filed a lawsuit for patent infringement against Medtronic, Inc., which, as amended, alleged infringement of three Edwards Lifesciences United States patents. On September 18, 2001, Edwards Lifesciences filed a separate complaint against Medtronic alleging infringement of a fourth Edwards Lifesciences United States patent. These lawsuits were filed in the United States District Court for the District of Delaware. Effective April 24, 2002, Edwards Lifesciences entered into an agreement with Medtronic resolving these patent infringement claims and dismissing the two lawsuits. Under the terms of the settlement, Edwards Lifesciences received a one-time cash payment of $20.0 million (recorded as a gain of $14.7 million, net of legal expenses, in Other (Income) Expense, net) and granted Medtronic a royalty-bearing license on two of the Edwards Lifesciences' patents. In addition, on July 2, 2002, Edwards Lifesciences and Medtronic submitted to binding arbitration on another of the patents in dispute. Medtronic prevailed in this arbitration and will not require an additional license.

        On June 29, 2000, Edwards Lifesciences also filed a lawsuit against St. Jude Medical, Inc. alleging infringement of three Edwards Lifesciences United States patents. This lawsuit was filed in the United States District Court for the Central District of California, seeking monetary damages and injunctive relief. St. Jude has answered and asserted various affirmative defenses and counterclaims with respect to the lawsuits. On April 9, 2002, the court granted Edwards Lifesciences' motion to amend the complaint to add a fourth Edwards Lifesciences United States patent and ordered St. Jude to dismiss a lawsuit it had filed against the Company in Minnesota related to the same patent.

        Edwards Lifesciences is, or may be, a party to, or may be otherwise 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 and complexities, 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 pending legal matters, Edwards Lifesciences may incur charges in excess of presently established reserves. While such a charge could have a material adverse impact on Edwards Lifesciences' net income or net cash flows in the period in which it is recorded or paid, management believes that no such charge would have a material adverse effect on Edwards Lifesciences' consolidated financial position.

        Edwards Lifesciences also 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 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.

8. SEGMENT INFORMATION

        Edwards Lifesciences manages its business on the basis of one reportable segment. The Company's products and technologies share similar distribution channels and customers and are sold principally to hospitals and physicians. Management evaluates its various global product portfolios on a revenue basis,

7



which is presented below, and profitability is generally evaluated on an enterprise-wide basis due to shared infrastructures. Edwards Lifesciences' principal markets are the United States, Europe and Japan.

        Geographic area data includes net sales, based on product shipment destination, and long-lived assets, based on physical location.

 
  Three Months
Ended June 30,

  Six Months
Ended June 30,

 
  2002
  2001
  2002
  2001
 
  (in millions)

Net Sales by Geographic Area                        
United States   $ 98.4   $ 123.2   $ 193.2   $ 246.5
Europe     39.2     37.2     75.7     74.6
Japan     15.5     15.7     31.7     30.9
Other countries     19.7     16.3     34.5     32.3
   
 
 
 
    $ 172.8   $ 192.4   $ 335.1   $ 384.3
   
 
 
 

Net Sales by Major Product and Service Lines

 

 

 

 

 

 

 

 

 

 

 

 
Cardiac Surgery   $ 92.8   $ 85.1   $ 180.5   $ 170.0
Critical Care     55.2     53.9     107.8     106.1
Vascular     13.0     12.7     24.8     25.8
Perfusion     11.1     40.1     20.6     81.4
Other     0.7     0.6     1.4     1.0
   
 
 
 
    $