o Strong Sales Growth of Critical Care and Vascular
o Magna Mitral U.S. Approval Timeline Extended
o Distribution Agreement in Japan to be Terminated
IRVINE, Calif., October 22, 2007 - 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 September 30, 2007 of $29.1 million, or $0.48 per diluted share, compared to net income of $27.8 million, or $0.45 per diluted share for the same period in 2006. Excluding special items detailed in the reconciliation table below, third quarter 2007 net income was $27.6 million, or $0.46 per diluted share, compared to net income of $29.0 million, or $0.47 per diluted share for the previous year.
Third quarter net sales increased 5.7 percent to $261.4 million, compared to $247.4 million in the same quarter last year. Underlying sales growth was 7.8 percent excluding the impact of $10.3 million of sales from discontinued products and a $5.6 million contribution from foreign exchange.
"We are pleased to report solid third quarter results, in which total underlying sales growth trended up to 7.8%," said Michael A. Mussallem, Edwards Lifesciences' chairman and CEO. "Once again, our Critical Care and Vascular franchises made a substantial contribution to overall growth."
"In addition, we reached another significant milestone during the quarter, as we received CE Mark to begin selling the Edwards SAPIEN transcatheter heart valve in Europe," said Mussallem.
For the third quarter, the company reported Heart Valve Therapy sales of $122.8 million, a 4.7 percent increase, which included a $2.7 million positive contribution from foreign exchange. "We are continuing to see global growth in our line of Magna valves, which achieved double-digit growth this quarter," said Mussallem. "While we are looking forward to introducing our Magna mitral valve in the U.S., we are responding to questions from the FDA and are no longer confident of a fourth quarter approval."
Critical Care sales of $96.5 million grew 13.7 percent, which included a $2.0 million positive contribution from foreign exchange. "Critical Care achieved its strongest quarterly growth rate this year," said Mussallem. "Global sales of our FloTrac system continued to be the biggest growth driver, with share gains in pressure monitoring products also contributing."
Cardiac Surgery Systems sales for the quarter were $13.8 million, a decline from $21.5 million in the same quarter last year, due to last year's sale of the company's Brazil-based perfusion product line and this year's sale of the TMR product line.
Vascular sales grew 27.3 percent compared to the same period in 2006 to $22.4 million. "The very strong growth this quarter was driven by global sales of our LifeStent product line," added Mussallem.
"Additionally, we are making progress toward a landmark PMA approval for our stent in the SFA position and are looking forward to the one-year clinical trial data being presented at the TCT conference tomorrow. However, we will not receive the approval by the end of this year as we are currently responding to additional FDA questions."
Domestic and international sales for the third quarter were $118.1 million and $143.3 million, respectively.
Termination of Distributed Product Line in Japan
As part of Edwards' ongoing strategy to focus on proprietary products, the company decided to terminate its distribution of a third-party's line of intra aortic balloon pumps in Japan. "This will enable our Japan operations to further increase their focus on selling the FloTrac and PreSep systems, our recently approved critical care products," stated Mussallem.
The parties are terminating the distribution agreement at year-end. This product line represents approximately $27 million of annual sales. Edwards anticipates this action will have a moderately dilutive impact in 2008; however, with this increased sales focus, it is expected to be accretive in 2009.
Additional Operating Results
For the quarter, Edwards' gross profit margin was 65.3 percent compared to 64.7 percent in the same period last year. The increase was due to a more profitable product mix and the positive impact from foreign exchange, partially offset by operating costs specific to the quarter.
Selling, general and administrative expenses were $103.2 million for the quarter, or 39.5 percent of sales. This expected higher level of spending was due to additional investments for the Edwards SAPIEN transcatheter valve launch in Europe, higher sales-related spending in the U.S. and the impact of foreign exchange.
Research and development expenses were $30.9 million for the quarter, or 11.8 percent of sales. The increased level of spending was primarily for transcatheter valve and critical care development efforts.
During the quarter, a third-party warehouse fire destroyed the company's inventory in Brazil. This fire did not result in a significant disruption of Edwards' operations. The company recorded a $2.5 million special pre-tax gain in the quarter in connection with the estimated insurance settlement.
Free cash flow generated during the quarter was $43.7 million, calculated as cash flow from operating activities of $59.4 million minus capital expenditures of $15.7 million. Total debt at September 30, 2007 was $211.2 million. Cash and cash equivalents were $175.7 million at the end of the quarter, resulting in net debt of $35.5 million.
In the quarter, the company repurchased 1 million shares of common stock for $47.4 million.
For the nine months ended September 30, 2007, the company recorded net income of $97.2 million, or $1.59 per diluted share, compared to $109.8 million, or $1.76 per diluted share for the same period of 2006. Excluding special items detailed in the reconciliation table below, non-GAAP net income for the first nine months in 2007 was $95.7 million, or $1.57 per diluted share, compared to net income of $94.0 million, or $1.51 per diluted share for the previous year.
Net sales for the first nine months of 2007 totaled $798.1 million, an increase of 3.5 percent over the same period last year. Foreign exchange contributed $16.8 million to the period's growth and was more than offset by discontinued businesses of $31.4 million. Underlying growth was 5.5 percent for the first nine months. Domestic and international sales for the first nine months were $362.7 million and $435.4 million, respectively.
Free cash flow generated in the first nine months was $90.2 million, calculated as cash flow from operating activities of $133.3 million minus capital expenditures of
"Our previous full-year expectations remain unchanged," said Mussallem. "However, results may trend toward the lower end of our sales and earnings guidance ranges if Magna mitral is not approved in the fourth quarter.
"Specifically, for full-year 2007, we expect total sales between $1.070 to $1.110 billion. For Heart Valve Therapy, we expect sales between $510 to $520 million. In Critical Care, we are maintaining our guidance of $385 to $395 million. In Cardiac Surgery Systems, we expect sales between $55 to $60 million. Lastly, in Vascular, we still project sales of $85 to $95 million. All of these projections assume foreign currencies remain at current levels.
"At current FX levels, we project fourth quarter diluted EPS of $0.52 to $0.54 and are comfortable with our previous 2007 diluted EPS guidance of $2.08 to $2.12, excluding special items," stated Mussallem.
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 opportunities including heart valve disease, peripheral 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, LifeStent, PERIMOUNT Magna, and Swan-Ganz. Additional company information can be found at www.edwards.com.
Amanda C. Fowler,