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Edwards Lifesciences Reports Strong Fourth Quarter Sales
Date:2/5/2008

- Critical Care Reports 20 Percent Growth

- Gross Profit Margin Reaches 66 Percent

- Special Items Reduce Net Income by $17.9 Million

IRVINE, Calif., Feb. 5 /PRNewswire-FirstCall/ -- Edwards Lifesciences Corporation (NYSE: EW), a world leader in products and technologies to treat advanced cardiovascular disease, today reported net income for the quarter ended December 31, 2007 of $15.8 million, or $0.27 per diluted share, compared to net income of $20.7 million, or $0.34 per diluted share for the same period in 2006. Excluding special items detailed in the reconciliation table below, fourth quarter 2007 net income was $33.7 million, or $0.56 per diluted share, compared to net income of $33.7 million, or $0.55 per diluted share for the previous year.

Fourth quarter net sales increased 10.3 percent to $293.0 million, compared to $265.6 million in the same quarter last year. Underlying sales growth was 9.7 percent excluding the impact of $11.4 million of sales from discontinued products and a $13.4 million contribution from foreign exchange.

"Our Critical Care franchise achieved 10 percent sales growth for full year 2007, capped by a very strong fourth quarter," said Michael A. Mussallem, Edwards Lifesciences' chairman and CEO. "In the quarter, our market-leading Heart Valve Therapy franchise reported 9 percent growth and was led by strong international sales.

"With the successful launch of our SAPIEN valve in Europe, transcatheter heart valves contributed over $2 million of sales in the fourth quarter. We continue to build momentum and are confident we will achieve more than $20 million of global transcatheter heart valve sales in 2008," continued Mussallem.

"W8)

Common stock in treasury, at cost (470.3) (339.4)

Total stockholders' equity 835.0 749.4

Total liabilities and stockholders' equity $1,345.1 $1,246.8

(1) Effective January 1, 2007, the Company adopted Financial Accounting

Standard Board ("FASB") Interpretation No. 48, "Accounting for

Uncertainty in Income Taxes, an interpretation of FASB Statement

No. 109" ("FIN 48"). The adoption of FIN 48 increased the January 1,

2007 balance of retained earnings by $1.7 million.

EDWARDS LIFESCIENCES CORPORATION

Non-GAAP Financial Information

To supplement the consolidated financial results prepared in accordance with Generally Accepted Accounting Principles ("GAAP"), the Company uses non-GAAP financial measures that exclude certain items, such as in-process research and development expenses, special charges and gains, results of discontinued products, and fluctuations in exchange rates. Management does not consider the excluded items part of day-to-day business or reflective of the core operational activities of the Company as they result from transactions outside the ordinary course of business.

Management uses non-GAAP financial measures internally for strategic decision making, forecasting future results and evaluating current performance. Certain guidance is provided only on a non-GAAP basis that excludes special items and foreign exchange fluctuations due to the inherent difficulty in forecasting such items. By disclosing non-GAAP financial measures, management intends to provide investors with a more meaningful, consistent comparison of the Company's core operating results and trends for the periods presented.

"Non-GAAP financial measures are not prepared in accordance with GAAP; therefore, the information is not necessarily comparable to other companies and should be considered as a supplement to, not a substitute for, nor superior to, the corresponding measures calculated in accordance with GAAP.

The items described below are excluded from the GAAP financial results in the reconciliations that follow:

Cost of Goods Sold -- The Company incurred a $2.0 million charge in the fourth quarter of 2006 for the inventory written off as a result of the discontinuance of the Optiwave Laser Ablation System. Given the magnitude and unusual nature of this expense relative to the operating results for the period presented, this expense has been excluded in non-GAAP net income.

Special Charges (Gains), net -- The Company incurred certain special charges and gains in 2007 and 2006 related to the following:

1) Realignment expenses: $13.9 million charge for a worldwide realignment

of resources, primarily related to severance expenses for the sale of

the LifeStent product line and the termination of the Company's

intra-aortic balloon pump distribution agreement in Japan in the fourth

quarter 2007; $7.3 million charge for severance expenses resulting from

a resource realignment in the fourth quarter of 2006, and a

$2.1 million charge primarily for severance expenses in the first

quarter of 2006 resulting from the planned closing of a manufacturing

facility;

2) Pension settlement and adjustment: $7.1 million charge related to the

termination of the Puerto Rico pension plan and a $4.1 million

adjustment to apply SFAS 87 accounting to a Switzerland pension plan in

the fourth quarter of 2007;

3) Reversal of gain on estimated insurance settlement: $2.5 million

charge in the fourth quarter of 2007 to reverse the $ 2.5 million gain

recorded in the third quarter of 2007 from the estimated insurance

settlement from a fire that destroyed certain inventory held at a third

party warehouse in Brazil; this gain will be recognized upon receiving

the settlement;

4) Gain on sale of assets, net: $1.8 million gain from the sale of real

estate development rights in the fourth quarter of 2007; $6.1 million

gain from the sale of the angiogenesis program in the fourth quarter of

2006, $4.5 million gain from the sale of a non-strategic business in

the second quarter of 2006, $2.6 million charge in the second quarter

of 2006 related to the revaluation of the Company's remaining

international perfusion product assets which were sold in

December 2006; and $5.7 million gain from cash received in the first

quarter of 2006 as the final earn-out payment in the prior year's sale

of the Japan Perfusion product line;

5) Gain on patent settlement: $20.2 million gain from a patent settlement

with Medtronic in the first quarter of 2006;

6) PVT milestone: $10.0 million charge for achieving a transcatheter

clinical milestone with PVT, Inc. in the fourth quarter of 2006;

7) Discontinued products: $6.8 million charge for discontinuance of the

Optiwave Laser Ablation System in the fourth quarter of 2006;

8) Restructure 3F Therapeutics agreements: $2.0 million charge for the

final obligation to 3F in the third quarter of 2006 for the prior

year's restructuring of the 3F Therapeutics agreement;

9) Litigation reserve: $1.2 million charge for litigation reserves in the

second quarter of 2006.

Given the magnitude and unusual nature of these special charges and gains relative to the operating results for the periods presented, these items have been excluded from non-GAAP net income.

Provision For Income Taxes -- The Company benefited from $3.2 million of favorable audit settlements in the fourth quarter of 2006 and benefited $3.7 million in the second quarter of 2006 related to the reversal of a valuation allowance, triggered by the gain from the sale of a product line. Given the magnitude and unusual nature of these tax events relative to the periods presented, these items have been excluded from non-GAAP net income.

Results of Discontinued Products -- The Company has discontinued certain products during the periods presented. As discontinued products do not have a continuing contribution to operations, management believes that excluding such items from the Company's sales growth provides investors with a means of evaluating the Company's on-going operations. In light of the significance of the impact these products had on the sales growth of the Company, the sales results of these products have been detailed in the "Unaudited Reconciliation of Sales by Product Line and Region."

Foreign Exchange -- Fluctuation in exchange rates impacts the comparative results and sales growth rates of the Company's underlying business. Management believes that excluding the impact of foreign exchange rate fluctuations from its sales growth provides investors a more meaningful comparison to historical financial results. The impact of foreign exchange rate fluctuations has been detailed in the "Unaudited Reconciliation of Sales by Product Line and Region."

EDWARDS LIFESCIENCES CORPORATION

Reconciliation of GAAP to Non-GAAP Financial Information

Three Months

Ended Year Ended

December 31, December 31,

(in millions, except per share data) 2007 2006 2007 2006

GAAP net income $15.8 $20.7 $113.0 $130.5

Reconciling items:

Cost of goods sold

Discontinued product - 2.0 - 2.0

Special charges (gains), net

1) Realignment expenses 13.9 7.3 13.9 9.4

2) Pension settlement and adjustment 11.2 - 11.2 -

3) Reversal of gain on estimated

insurance settlement 2.5 - - -

4) Gain on sale of assets, net (1.8) (6.1) (1.8) (13.7)

5) Gain on patent settlement - - - (20.2)

6) PVT milestone - 10.0 - 10.0

7) Discontinued products - 6.8 - 6.8

8) Restructure 3F Therapeutics

agreements - - - 2.0

9) Litigation reserve - - - 1.2

Total special charges (gains), net 25.8 18.0 23.3 (4.5)

Provision (benefit) for income taxes

Tax effect on non-GAAP adjustments

(A) (7.9) (3.8) (6.9) 6.6

Tax audit settlements - (3.2) - (3.2)

Tax benefit from reversal of

valuation allowance - - - (3.7)

Total benefit for income taxes, net (7.9) (7.0) (6.9) (0.3)

Non-GAAP net income $33.7 $33.7 $129.4 $127.7

Non-GAAP earnings per share:

Basic non-GAAP earnings per share $0.59 $0.58 $2.26 $2.18

Diluted non-GAAP earnings per share

(B) $0.56 $0.55 $2.13 $2.06

Non-GAAP weighted average shares

outstanding:

Basic 56.7 57.7 57.3 58.5

Diluted 62.0 63.2 62.7 63.9

GAAP Gross profit margin 66.0% 63.3% 65.3% 64.0%

Effect of Discontinued product - 0.8% - 0.2%

Non-GAAP Gross profit margin 66.0% 64.1% 65.3% 64.2%

Notes 1 -- 9: See description of Special Charges (Gains), net on the

previous page.

(A) The tax effect on non-GAAP adjustments is calculated using the

relevant tax jurisdictions' statutory tax rates.

(B) Diluted non-GAAP earnings per share is calculated by adding back to

net income $1.0 million for the quarter in interest expense related

to the convertible debt for the quarter, and $4.0 million for the

full year, then dividing by the weighted average diluted shares

outstanding.

Note: Numbers may not calculate due to rounding

EDWARDS LIFESCIENCES CORPORATION

Unaudited Reconciliation of Sales by Product Line and Region

(in millions)

2007 Adjusted

Discontinued 4Q

GAAP Product 2007

Sales by Product Line 4Q 4Q Growth Line Underlying

(QTD) 2007 2006 Change Rate Impact Sales

Heart Valve Therapy $131.4 $120.6 $10.8 9.0% $(0.8) $130.6

Critical Care 113.0 94.2 18.8 20.0% - 113.0

Cardiac Surgery

Systems 15.1 21.9 (6.8) (31.1%) (0.8) 14.3

Vascular 25.1 21.0 4.1 19.5% - 25.1

Other Distributed

Products 8.4 7.9 0.5 6.3% - 8.4

Total Sales $293.0 $265.6 $27.4 10.3% $(1.6) $291.4

2006 Adjusted

Discontinued

Product 4Q 2006 Underlying

Line FX Underlying Growth

Sales by Product Line (QTD) Impact Impact Sales Rate *

Heart Valve Therapy $(3.3) $6.4 $123.7 5.7%

Critical Care - 4.8 99.0 14.4%

Cardiac Surgery Systems (9.0) 0.9 13.8 4.3%

Vascular (0.7) 1.1 21.4 17.1%

Other Distributed Products - 0.2 8.1 3.7%

Total Sales $(13.0) $13.4 $266.0 9.7%

2007 Adjusted

Discontinued YTD

YTD YTD GAAP Product 2007

Sales by Product Line 4Q 4Q Growth Line Underlying

(YTD) 2007 2006 Change Rate Impact Sales

Heart Valve Therapy $515.0 $490.8 $24.2 4.9% $(5.8) $509.2

Critical Care 397.8 349.8 48.0 13.7% - 397.8

Cardiac Surgery

Systems 60.9 91.0 (30.1) (33.1%) (6.2) 54.7

Vascular 90.0 75.9 14.1 18.6% - 90.0

Other Distributed

Products 27.4 29.5 (2.1) (7.1%) - 27.4

Total Sales $1,091.1 $1,037.0 $54.1 5.2% $(12.0) $1,079.1

2006 Adjusted

Discontinued

Product YTD 2006 Underlying

Line FX Underlying Growth

Sales by Product Line (YTD) Impact Impact Sales Rate *

Heart Valve Therapy $(12.5) $14.9 $493.2 3.2%

Critical Care - 10.4 360.2 10.4%

Cardiac Surgery Systems (38.9) 1.5 53.6 2.1%

Vascular (2.5) 3.0 76.4 17.8%

Other Distributed Products (0.9) 0.4 29.0 (3.5%)

Total Sales $(54.8) $30.2 $1,012.4 6.6%

GAAP

Growth

Sales by Region (QTD) 4Q 2007 4Q 2006 Change Rate

United States $123.9 $119.3 $4.6 3.9%

Europe 85.7 69.8 15.9 22.8%

Japan 50.6 44.2 6.4 14.5%

Rest of World 32.8 32.3 0.5 1.5%

International 169.1 146.3 22.8 15.6%

Total $293.0 $265.6 $27.4 10.3%

GAAP

YTD 4Q YTD 4Q Growth

Sales by Region (YTD) 2007 2006 Change Rate

United States $486.6 $477.9 $8.7 1.8%

Europe 309.1 264.6 44.5 16.8%

Japan 171.4 168.8 2.6 1.5%

Rest of World 124.0 125.7 (1.7) (1.4%)

International 604.5 559.1 45.4 8.1%

Total $1,091.1 $1,037.0 $54.1 5.2%

* Numbers may not calculate due to rounding.

e are the first company to provide the Ascendra transapical delivery system, which was recently approved for sale in Europe and just last week was cleared by the FDA to be included in our U.S. PARTNER trial."

Sales Results

For the fourth quarter, the company reported Heart Valve Therapy sales of $131.4 million, which included a $6.4 million positive contribution from foreign exchange. "Strong sales growth in international markets, driven by recent product launches and share gains, is offsetting a U.S. market that remains competitive," said Mussallem.

Critical Care sales of $113.0 million grew 20.0 percent over last year, which included a $4.8 million positive contribution from foreign exchange. "Sales of new products, led by our FloTrac system, continued to be the biggest growth driver this quarter," added Mussallem. "Our world-leading pressure monitoring products continued to gain share. In addition, growth was boosted by a sharp up-tick in sales of hardware products."

Cardiac Surgery Systems sales for the quarter were $15.1 million, a decline from $21.9 million in the same quarter last year due to the 2006 sale of the company's Brazil-based perfusion product line and this year's sale of the TMR product line. "During the quarter, we completed our acquisition of CardioVations and are excited about integrating these minimally invasive products into our portfolio," stated Mussallem.

Vascular sales grew 19.5 percent to $25.1 million compared to the same period in 2006. "The strong growth this quarter was driven by global sales of the LifeStent product line," Mussallem said. "Consistent with our long-term strategy, we completed the sale of the LifeStent product line in January."

Domestic and international sales for the fourth quarter were $123.9 million and $169.1 million, respectively.

Additional Operating Results

For the quarter, Edwards' gross profit margin was 66.0 percent compared to 63.3 percent in the same period last year, driven primarily by a more profitable product mix.

Selling, general and administrative expenses were $114.5 million for the quarter, or 39.1 percent of sales, compared to $95.1 million last year. This increase was due to expected higher levels of spending for both the Edwards SAPIEN transcatheter heart valve launch in Europe and sales-related costs in the U.S., as well as the impact from foreign exchange.

Research and development expenses were $33.5 million for the quarter, or 11.4 percent of sales, compared to $30.0 million last year. The increased level of spending was focused primarily on the company's transcatheter valve and critical care development efforts.

During the quarter, Edwards recorded a net $25.8 million pre-tax special charge, primarily resulting from worldwide realignment charges of $13.9 million, principally related to the recently completed sale of the LifeStent product line, and pension plan related charges of $11.2 million, largely related to the previously announced closing of the company's Puerto Rico employee pension plan. The total charge is detailed in the reconciliation table below.

Free cash flow generated during the quarter was $63.0 million, calculated as cash flow from operating activities of $76.9 million minus capital expenditures of $13.9 million. Total debt at December 31, 2007 was $211.7 million. Cash and cash equivalents were $141.8 million at the end of the quarter, resulting in net debt of $69.9 million.

In the quarter, the company repurchased 475,000 shares of common stock for $23.7 million.

Twelve-Month Results

For the full year ended December 31, 2007, the company recorded net income of $113.0 million, or $1.87 per diluted share, compared to $130.5 million, or $2.10 per diluted share for the same period of 2006. Excluding special items detailed in the reconciliation table below, non-GAAP net income for full year 2007 was $129.4 million, or $2.13 per diluted share, compared to net income of $127.7 million, or $2.06 per diluted share for the previous year.

Net sales for the year totaled $1.091 billion, an increase of 5.2 percent over the same period last year. Underlying growth was 6.6 percent for the full year as foreign exchange contributed $30.2 million to the period's growth and was more than offset by discontinued businesses of $42.8 million. Domestic and international sales for the full year were $486.6 million and $604.5 million, respectively.

Free cash flow generated for the year was $153.2 million, calculated as cash flow from operating activities of $210.2 million minus capital expenditures of $57.0 million.

2008 Outlook

"Edwards is very well positioned for a strong 2008, highlighted by a number of new product launches and progress on our pioneering transcatheter heart valve platform," said Mussallem. "We also will remain focused on achieving our annual financial goals, which include generating total sales between $1.160 to $1.210 billion, increasing our gross profit margin by 100 to 150 basis points, and generating free cash flow of $155 to $165 million. Finally, we estimate that first quarter 2008 diluted EPS will be between $0.47 and $0.51, and for the full year between $2.32 and $2.40."

About Edwards Lifesciences

Edwards Lifesciences, a leader in advanced cardiovascular disease treatments, is the number-one heart valve company in the world and the global leader in acute hemodynamic monitoring. Headquartered in Irvine, Calif., Edwards focuses on specific cardiovascular disease states including heart valve disease, vascular disease and critical care technologies. The company's global brands, which are sold in approximately 100 countries, include Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, PERIMOUNT Magna, and Swan-Ganz. Additional company information can be found at http://www.edwards.com.

Conference Call and Webcast Information

Edwards Lifesciences will be hosting a conference call today at 5:00 p.m. ET to discuss its fourth quarter results. To participate in the conference call, dial (877) 407-8037 or (201) 689-8037. For 72 hours following the call, an audio replay can be accessed by dialing (877) 660-6853 or (201) 612-7415 and using account number 2995 and conference number 270419. The call will also be available via live or archived webcast on the "Investor Relations" section of the Edwards' web site at http://www.edwards.com or http://www.edwards.com/InvestorRelations.

This news release includes 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. These forward-looking statements include, but are not limited to, the company's ability to achieve financial goals for sales, gross profit margin, net income, earnings per share and free cash flow; regulatory approval of new products in, and competitive dynamics associated with, the company's heart valve therapy product line; the continued adoption and sales of the FloTrac system; the timing and progress of clinical studies relating to the company's transcatheter valve technologies and the market opportunity for these products; and the impact on the company's results of foreign exchange and special items. Forward-looking statements are based on estimates and assumptions made by management of the company and are believed to be reasonable, though they are inherently uncertain and difficult to predict.

Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Factors that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements include the opportunities for the company's transcatheter valve programs and the ability of the company to continue to lead in the development of this field; the success and timing of new product launches; the impact of currency exchange rates; the timing or results of pending or future clinical trials; actions by the U.S. Food and Drug Administration and other regulatory agencies; and other risks detailed in the company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2006.

To supplement the consolidated financial results prepared in accordance with Generally Accepted Accounting Principles ("GAAP"), the company uses non-GAAP financial measures that exclude certain items, such as in-process research and development expenses, special charges and gains, results of discontinued product lines, and fluctuations in exchange rates. Management does not consider the excluded items part of day-to-day business or reflective of the core operational activities of the company as they result from transactions outside the ordinary course of business. Management uses non-GAAP financial measures internally for strategic decision making, forecasting future results and evaluating current performance. Certain guidance is provided on a non-GAAP basis that excludes special items and foreign exchange fluctuations due to the inherent difficulty in forecasting such items. By disclosing non-GAAP financial measures, management intends to provide investors with a more meaningful, consistent comparison of the company's core operating results and trends for the periods presented. Non-GAAP financial measures are not prepared in accordance with GAAP; therefore, the information is not necessarily comparable to other companies and should be considered as a supplement to, not a substitute for, or superior to, the corresponding measures calculated in accordance with GAAP.

Edwards, and Edwards SAPIEN are trademarks of Edwards Lifesciences Corporation. Edwards Lifesciences, Carpentier-Edwards, Cosgrove-Edwards, FloTrac, Fogarty, Magna, PERIMOUNT Magna, and Swan-Ganz are trademarks of Edwards Lifesciences Corporation and are registered in the United States Patent and Trademark Office.

EDWARDS LIFESCIENCES CORPORATION

Unaudited Consolidated Statements of Operations

Three Months

Ended Year Ended

December 31, December 31,

(in millions, except per share data) 2007 2006 2007 2006

Net sales $293.0 $265.6 $1,091.1 $1,037.0

Cost of goods sold 99.6 97.4 378.2 373.6

Gross profit 193.4 168.2 712.9 663.4

Selling, general and administrative

expenses 114.5 95.1 418.0 376.0

Research and development expenses 33.5 30.0 122.3 114.2

Special charges (gains), net 25.8 18.0 23.3 (4.5)

Interest expense, net 0.4 0.4 1.4 2.7

Other (income) expenses, net (0.4) 1.0 (1.9) 2.7

Income before provision for income

taxes 19.6 23.7 149.8 172.3

Provision for income taxes 3.8 3.0 36.8 41.8

Net income $15.8 $20.7 $113.0 $130.5

Earnings per share:

Basic earnings per share $0.28 $0.36 $1.97 $2.23

Diluted earnings per share $0.27 $0.34 $1.87 $2.10

Weighted average common shares

outstanding:

Basic 56.7 57.7 57.3 58.5

Diluted 59.3 60.4 62.7 63.9

Operating Statistics

As a percentage of net sales:

Gross profit 66.0% 63.3% 65.3% 64.0%

Selling, general and

administrative expenses 39.1% 35.8% 38.3% 36.3%

Research and development expenses 11.4% 11.3% 11.2% 11.0%

Income before provision for

income taxes 6.7% 8.9% 13.7% 16.6%

Net income 5.4% 7.8% 10.4% 12.6%

Effective tax rate 19.4% 12.7% 24.6% 24.3%

Computation of Diluted Earnings per

Share

Net income $15.8 $20.7 $113.0 $130.5

Adjustment for convertible debt

interest expense - - 4.0 4.0

Adjusted net income $15.8 $20.7 $117.0 $134.5

Weighted average common shares

outstanding used to calculate diluted

earnings per share

excluding convertible debt 59.3 60.4 60.0 61.2

Weighted average common shares

outstanding for the convertible debt - - 2.7 2.7

Weighted average common shares

outstanding used to calculate diluted

earnings per share including the

convertible debt 59.3 60.4 62.7 63.9

Diluted earnings per share including

the convertible debt $0.27 $0.34 $1.87 $2.10

Note: Numbers may not foot due to rounding

EDWARDS LIFESCIENCES CORPORATION

Unaudited Balance Sheets

(in millions)

December 31, December 31,

2007 2006

ASSETS

Current assets

Cash and cash equivalents $141.8 $182.8

Short-term investments 49.4 -

Accounts and other receivables, net 145.3 127.1

Inventories, net 152.6 142.1

Deferred income taxes 30.2 21.8

Prepaid expenses 25.4 25.7

Other current assets 37.0 32.1

Total current assets 581.7 531.6

Property, plant and equipment, net 228.2 213.0

Goodwill 350.3 337.7

Other intangible assets, net 122.5 116.1

Investments in unconsolidated affiliates 34.3 20.2

Deferred income taxes 13.8 14.5

Other assets 14.3 13.7

Total assets $1,345.1 $1,246.8

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities

Accounts payable and accrued liabilities $225.4 $226.2

Convertible debt 150.0 -

Total current liabilities 375.4 226.2

Long-term debt 61.7 235.9

Other long-term liabilities 73.0 35.3

Stockholders' equity

Common stock 68.6 67.0

Additional contributed capital 680.6 603.7

Retained earnings (1) 548.6 433.9

Accumulated other comprehensive income (loss) 7.5 (15.
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SOURCE Edwards Lifesciences Corporation
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