Edwards Lifesciences Corporation Reports Solid Fourth Quarter Results

IRVINE, CA--(Marketwire - February 02, 2012) - Edwards Lifesciences Corporation (NYSE: EW), the global leader in the science of heart valves and hemodynamic monitoring, today reported net income for the quarter ended December 31, 2011 of $63.1 million, or $0.53 per diluted share, compared to net income of $64.8 million, or $0.54 per diluted share, for the same period in 2010. Excluding special items from both periods detailed in the reconciliation table below, fourth quarter diluted earnings per share were $0.62, compared to $0.55 in the prior year quarter, an increase of 12.7 percent.

Fourth quarter net sales increased 9.6 percent to $430.2 million compared to the same period last year. Underlying(1) sales growth was 8.3 percent.

"Our fourth quarter closes out a year of significant investment and major milestones for Edwards. Successful PARTNER trial results culminated in U.S. regulatory approval to begin offering our transcatheter heart valve technology to many inoperable patients suffering from severe aortic stenosis," said Michael A. Mussallem, chairman and CEO. "Although the SAPIEN approval was later than we anticipated and the recent economic turmoil in southern Europe affected results, we were able to deliver quarterly sales growth of 9.6 percent, consistent with our most recent guidance."

Sales Results
For the fourth quarter, the company reported Heart Valve Therapy sales of $256.6 million, representing 13.4 percent growth over last year. Underlying sales grew 12.5 percent. Transcatheter heart valve (THV) sales were $93.2 million, a 42.7 percent increase over 2010. Total THV commercial and clinical sales in the U.S. were $17.1 million.

"We continue to project full year 2012 THV sales of $560 to $630 million, including $200 to $260 million of sales in the U.S., which translates to a 70 to 90 percent underlying sales growth rate," Mussallem said.

Surgical heart valve sales were $163.4 million this quarter, a 1.6 percent increase over last year. Outside the U.S., sales grew 7.2 percent driven primarily by strong sales of premium products in Asia. In the U.S., sales declined this quarter due to the 2011 introduction of a competitor's product, combined with estimated flat procedural volumes.

Critical Care sales were $133.3 million for the quarter, representing 4.5 percent growth over last year. Driving the growth this quarter were strong sales of advanced monitoring products, including EV1000 monitoring hardware and FloTrac.

Cardiac Surgery Systems sales increased to $27.2 million for the quarter, representing 8.0 percent growth over last year.

Vascular sales were $13.1 million, down slightly from the same quarter last year.

Domestic and international sales for the fourth quarter were $154.7 million and $275.5 million, respectively.

Additional Operating Results

For the quarter, gross profit margin was 72.2 percent compared to 71.1 percent in the same period last year. This improvement was driven primarily by a more profitable product mix.

Selling, general and administrative expenses were $163.4 million for the quarter, or 38.0 percent of sales, compared to $142.4 million in the prior year. This 14.7 percent increase was driven primarily by U.S. transcatheter launch-related investments.

Research and development expenses for the quarter grew 8.6 percent to $60.7 million, or 14.1 percent of sales. This increase was primarily the result of additional investments in the company's transcatheter valve programs.

Free cash flow for the quarter was $62.4 million, calculated as cash from operating activities of $94.7 million, minus capital expenditures of $32.3 million.

At December 31, 2011, cash and cash equivalents and short term investments were $450.5 million and total debt was $150.4 million.

During the quarter, the company repurchased approximately 560,000 shares of common stock for $40.1 million.

Special Items

During the quarter, the company recorded a pre-tax $17.6 million special charge related to southern European receivables risk, a global realignment charge and a legal settlement. In addition, during the quarter, the company recorded a $4.0 million favorable tax adjustment related to the release of a reserve.

Twelve-Month Results

For the twelve months ended December 31, 2011, the company recorded net income of $236.7 million, or $1.98 per diluted share, compared to $218.0 million, or $1.83 per diluted share, for the same period in 2010. Net income growth for the year was 8.6 percent, or 10.1 percent excluding special items in both periods. For the twelve months, diluted earnings per share increased 8.2 percent over last year, or 9.8 percent excluding special items in both periods.

Net sales for the twelve months of 2011 increased 16.0 percent to $1.68 billion. Underlying sales growth was 11.6 percent.

Domestic and international sales for the twelve months were $605.6 million and $1,073.0 million, respectively.

Free cash flow for the year was $183.2 million, calculated as cash from operating activities of $266.1 million, minus capital expenditures of $82.9 million. Free cash flow was lower than planned due to higher than expected inventories.

During 2011, the company repurchased approximately 3.9 million shares of common stock for $303.4 million.

Outlook
"As we look ahead, we see an exciting year for Edwards Lifesciences. We have just begun offering our life saving SAPIEN technology to many inoperable U.S. patients suffering from severe aortic stenosis and also anticipate making it available for patients whose conditions place them at high risk for surgery," said Mussallem.

"For the first quarter of 2012, we project total sales of $440 to $460 million and continue to expect full year sales of $1.95 to $2.05 billion. We estimate that first quarter diluted EPS will be between $0.47 and $0.49, excluding special items. For the full year 2012, we continue to estimate that diluted EPS will be between $2.70 and $2.80, excluding special items. In addition, excluding special items, we remain comfortable with our previously stated 2012 financial goals of a 73 to 75 percent gross profit margin, net income growth of 35 to 40 percent, and free cash flow between $240 and $260 million," Mussallem added. "These goals assume a mid-year 2012 approval of Cohort A of The PARTNER Trial."

About Edwards Lifesciences
Edwards Lifesciences is the global leader in the science of heart valves and hemodynamic monitoring. Driven by a passion to help patients, the company partners with clinicians to develop innovative technologies in the areas of structural heart disease and critical care monitoring that enable them to save and enhance lives. Additional company information can be found at 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 387244. The call will also be available via live or archived webcast on the "Investor Relations" section of the Edwards web site at www.edwards.com or 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 can sometimes be identified by the use of words such as "may," "will," "should," "anticipate," "believe," "plan," "project," "estimate," "expect," "intend," "guidance," "outlook," "optimistic," "aspire," "confident" or other forms of these words or similar expressions and include, but are not limited to, statements made by Mr. Mussallem, and the Company's financial goals or expectations for sales, FX impact, gross profit margin, net income and net income growth, earnings per share and earnings per share growth and free cash flow and other financial expectations. 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. Our forward-looking statements speak only as of the date on which they are made and we do not undertake any obligation to update any forward-looking statement to reflect events or circumstances after the date of the statement. If the Company does update or correct one or more of these statements, investors and others should not conclude that the Company will make additional updates or corrections.

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 uncertainties associated with the timing and extent of regulatory approval for additional indications, reimbursement levels for the SAPIEN valve and other new products; the ability of the Company to lead in the development of the THV field; the Company's success in developing new products and expanding its markets, creating new market opportunities for its products and avoiding manufacturing and quality issues; the availability and quality of competitive products; 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; economic developments in key markets such as southern Europe; unexpected litigation results or expense; 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, 2010.

To supplement the consolidated financial results prepared in accordance with Generally Accepted Accounting Principles ("GAAP"), the Company uses non-GAAP historical financial measures. The Company uses the term "underlying" when referring to non-GAAP sales information, which excludes discontinued and acquired products and foreign exchange fluctuations, and "excluding special items" to also exclude gains and losses from special items such as significant investments, litigation, and business development transactions. Guidance for sales and sales growth rates is provided on an "underlying" basis, and projections for diluted earnings per share, gross profit margin, net income and growth, and free cash flow are also provided on the same non-GAAP (or "excluding special items") basis due to the inherent difficulty in forecasting such items. 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. 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. These non-GAAP financial measures are used in addition to and in conjunction with results presented in accordance with GAAP and reflect an additional way of viewing aspects of the company's operations that, when viewed with its GAAP results, provide a more complete understanding of factors and trends affecting the company's business. These non-GAAP measures should be considered as a supplement to, and not as a substitute for, or superior to, the corresponding measures calculated in accordance with generally accepted accounting principles. Non-GAAP financial measures are not prepared in accordance with GAAP; therefore, the information is not necessarily comparable to other companies. A reconciliation of non-GAAP historical financial measures to the most comparable GAAP measure is provided in the tables below. The Company is not able to provide a reconciliation of projected gross profit margin, net income and growth, projected earnings per share guidance and projected free cash flow, excluding special items, to expected reported results due to the unknown effect, timing and potential significance of special charges or gains, and management's inability to forecast charges associated with future transactions and initiatives.

Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, Edwards SAPIEN XT, EV1000, FloTrac, PARTNER and SAPIEN are trademarks of Edwards Lifesciences Corporation.

(1) "Underlying" amounts are non-GAAP items and in this press release exclude exchange fluctuations. See the reconciliation tables below.