Previous Statements by EW
» Edwards Lifesciences' CEO Discusses Q4 2012 Results - Earnings Call Transcript
» Edwards Lifesciences CEO Discusses Q3 2011 Results - Earnings Call Transcript
» Edwards Lifesciences' CEO Discusses Q2 2011 Results - Earnings Call Transcript
» Edwards Lifesciences Corp. Q4 2009 Earnings Call Transcript
These statements also include our current expectations for regulatory submissions and approvals related to a variety of new products and indications in the U.S., Europe, and Japan, as well as the timing, status, and expected outcomes of new or currently ongoing clinical trials; the expected impact, benefits of, and market potential for new product introductions; expectations regarding market growth; and potential impacts of economic conditions and competitive products.These statements speak only as of the date on which they are made, and we do not undertake any obligation to update them after today. Although we believe them to be reasonable, these statements involve risks and uncertainties that could cause actual results or experiences to differ materially from the forward-looking statements. Information concerning factors that could cause these differences may be found in our press release, our annual report on Form 10-K for the year ended December 31, 2011, and our other SEC filings, which are available on our website at edwards.com. Also, a quick reminder that when we use the terms “underlying” and “excluding special items”, we are referring to non-GAAP financial measures. Otherwise, we are referring to our GAAP results. Additional information about our use of non-GAAP measures is included in today's press release. Now I'll turn the call over to Mike Mussallem. Mike? Michael Mussallem Thank you David. This quarter was highlighted by an impressive first quarter of SAPIEN commercialization in the United States. Additionally, we’re pleased that the growing body of longer-term evidence further supports the Edwards SAPIEN transcatheter valve as an important therapy. And, with a scheduled FDA panel for cohort A and our approaching national coverage decision, the near term U.S. transcatheter opportunity will become more clear. At the same time, given current dynamics, which we’ll discuss shortly, we are tempering the full year forecast for THV sales. And although we are lowering our overall 2012 expectations, excluding special items, we continue to expect underlying sales growth to be approximately 20% and earnings per share growth of 30%.
Before turning to the quarterly results, as a reminder, this year we’ve begun reporting sales in three new product groups: surgical heart valve therapy, which combines surgical heart valves and cardiac surgery systems; transcatheter heart valves and critical care, which includes vascular.Reported sales grew 14% to $459 million, primarily driven by the U.S. launch of SAPIEN. On an underlying sales basis, they grew 13%. Sales outside the U.S. grew 7% on a regular basis, and represent approximately 60% of total sales. For the first quarter, the surgical heart valve therapy product group grew 3% to $204 million, which included $28 million from cardiac surgery systems. Within this product group, surgical heart valves grew 2% over last year. Outside the U.S., our surgical heart valves grew 7%, driven primarily by penetration of our premium products in Europe and Japan. Product pricing remains stable in each region. However, strong growth in emerging markets changed the country mix, which slightly lowered our overall global average price. In the U.S., the continued impact of a competitor’s product introduction last year led to a modest decline in surgical heart valve sales this quarter. In the second half of 2012, we expect the impact to diminish as the competitive introduction annualizes. In Europe, we believe we gained share through the growth of our premium products. In Japan, we’re pleased that our Magna Mitral Ease valve was approved in the first quarter, and customers are actively converting to this state-of-the-art mitral valve. Recently, a competitor received an earlier than expected approval of an aortic pericardial valve. We expect these impacts in Japan to be somewhat offsetting for the remainder of the year. We continue to make good progress on our pipeline and are excited about the promise of these technologies. As previously announced, during the quarter we received CE mark for our Edwards INTUITY rapid deployment aortic valve system. As expected, we are initiating our CADENCE and Foundation European post-approval studies focused on the patient benefits and health economics of this new procedure compared to traditional open heart surgery. With this focus on clinical studies, we expect the INTUITY revenue contribution in 2012 to be modest, and to begin contributing to growth next year. Read the rest of this transcript for free on seekingalpha.com