Edwards Lifesciences Corp at Wells Fargo Securities Healthcare Conference Transcript

The following is excerpted from the question-and-answer section of the transcript. (Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session) Question: Larry Biegelsen - Wells Fargo Securities - Analyst: Thanks a lot, David. So in terms of format, I'll just kick it off with a couple of questions, but please feel free to just raise your hand if you have a question and I will walk the mic over. Why don't we just start with new competition in Europe. There's a lot of interest in new devices coming to the market after the TVT meeting a couple of weeks ago. We saw I think three or four devices that hope to have CE Mark later this year and a couple next year. What's your view of new competition in Europe? How might they affect pricing there? And I assume you plan to maintain market leadership. How are you going to accomplish that? Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Question: Larry Biegelsen - Wells Fargo Securities - Analyst: And price, pricing, price erosion? Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Question: Larry Biegelsen - Wells Fargo Securities - Analyst: In your pipeline, you talked about, at your analyst meeting in December 2010, that you would be in CE Mark trial with your next-generation device in 2012, but you did not divulge any details on your next-generation device. When were we going to get more visibility on that product? I assume if you're going to be in a CE Mark trial in 2012, you've got to do first in man before that, so we're in mid-2011. ¬2011 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Question: Larry Biegelsen - Wells Fargo Securities - Analyst: So turning to the US launch, which hopefully will occur in October or so of this year, that's your guidance -- we have a panel on July 20. What do you think -- given the strength of the data, which is very strong, what do you think maybe some of the key issues of that panel will be? Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Question: Larry Biegelsen - Wells Fargo Securities - Analyst: Can you talk a little bit about your -- sorry -- please. Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Question: Larry Biegelsen - Wells Fargo Securities - Analyst: When you think about the update in the US, you've given some metrics, $150 million to $250 million first-year, post-launch. I think that's your guidance. How do you think about it compared to Europe, the uptick obviously faster. But how much faster? And Germany is often pointed as a proxy or as a market because the uptake there has been very strong. Do you think the US can look like Germany? Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Question: Larry Biegelsen - Wells Fargo Securities - Analyst: Reimbursement -- you touched upon that as well. And on the first-quarter call, Mike said he thought CMS would eventually open a national coverage decision. What [gifts] in that sense? Is this something you see as a good thing? And what we have heard is that CMS is going to take a wait-and-see approach towards the national coverage decision. Would you guys agree? Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Question: Larry Biegelsen - Wells Fargo Securities - Analyst: PARTNER II? For Cohort B I think you said you expect to complete enrollment by the end of 2011. I assume that's still on track? Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Question: Larry Biegelsen - Wells Fargo Securities - Analyst: And on the first-quarter call, you said you were optimistic that you would receive approval for Cohort A of PARTNER II. Can you -- the quarter is almost over. Any update on that? There was some new information from the primary investigator at the DVT meeting, [Dr. Leon]. Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Question: Larry Biegelsen - Wells Fargo Securities - Analyst: And can you comment on what Dr. Leon said at the meeting about FDA wanting two-year follow-up in Cohort A? Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Question: Larry Biegelsen - Wells Fargo Securities - Analyst: Let me see if there any questions, please. ¬2011 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Question: Larry Biegelsen - Wells Fargo Securities - Analyst: Can you remind us, David, what the next step is in the CoreValve litigation? Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Question: Larry Biegelsen - Wells Fargo Securities - Analyst: Just switching gears to INTUITY, you talked about that a little bit, but can you try to put some numbers around it? What kind of price premium are you looking for? What's the opportunity? Which patients do you think are best suited for that valve? And how does it fit in with your surgical valve type products, current ones, and transcatheter valves? Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Question: Larry Biegelsen - Wells Fargo Securities - Analyst: If it's $10,000 to $15,000 because that's what 2 to 3 times a surgical valve would be, do you think you are going to need the cost-effectiveness data to drive sales in Europe? Or do you think it would be kind of like TAVI, where you we had a pretty rapid uptake, people -- and before you had the economic data? Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Question: Larry Biegelsen - Wells Fargo Securities - Analyst: And the Cohort A -- so PARTNER I Cohort A cost-effectiveness data, while we're on the topic -- when can we expect to see that? Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Question: Larry Biegelsen - Wells Fargo Securities - Analyst: TCT or AHA, or --? Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Question: Larry Biegelsen - Wells Fargo Securities - Analyst: And back to the US launch, one other question. In Europe you had a registry, like you had the Source registry. Do you plan to do the same thing in the United States? ¬2011 Thomson Reuters. All rights reserved. Republication or redistribution of Thomson Reuters content, including by Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR Question: Larry Biegelsen - Wells Fargo Securities - Analyst: With that, I think we're out of time, so David, thank you very much. Answer By: David Erickson - Edwards Lifesciences LLC - VP of IR

The following is excerpted from the question-and-answer section of the transcript.

(Questions from industry analysts are provided in full, but answers are omitted - download the transcript to see the full question-and-answer session)

Question: Larry Biegelsen - Wells Fargo Securities - Analyst: Thanks a lot, David. So in terms of format, I'll just kick it off with a couple of questions, but please feel free to just raise your hand if you have a question and I will walk the mic over. Why don't we just start with new competition in Europe. There's a lot of interest in new devices coming to the market after the TVT meeting a couple of weeks ago. We saw I think three or four devices that hope to have CE Mark later this year and a couple next year. What's your view of new competition in Europe? How might they affect pricing there? And I assume you plan to maintain market leadership. How are you going to accomplish that?