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| Sapien 3 valve--Courtesy of Edwards Lifesciences |
Edwards Lifesciences ($EW) bumped up its transcatheter heart valve sales estimate for 2015 due to what it anticipates will be a strong U.S. launch for its third-generation TAVR device, Sapien 3. It was approved in June within a day of an FDA approval for a similar device from Medtronic ($MDT), so the next quarter's earnings will start to tell the tale on how that U.S. next-gen TAVR competition will play out.
The company said it is already in the midst of a launch for Sapien 3, which it now expects will boost transcatheter heart valve therapy sales to hit the high end or slightly above its previously stated 2015 sales guidance for the business of $1 billion to $1.1 billion.
Based on this, it also raised its 2015 EPS to a range of $4.30 to $4.40, up from the prior range of $4.10 to $4.30. But it maintained its overall 2015 sales guidance of $2.3 billion to $2.5 billion.
Summed up Edwards Chairman and CEO Michael Mussallem on the earnings call, "We saw in Europe that when Sapien 3 was introduced that there was a step up in therapy adoption. And that that was meaningful. We think it's very possible that that's going to happen in the U.S. Clinician demand is very high."
"And you can see we obviously upped our estimate for transcatheter heart valve sales in the back half and some of it is because of SAPIEN 3 and that's going to, we think, is largely going to be market growth," he added, but cautioning, "Now at the same time, the competition is increasing and there is also an approval that our competitor got, so that's going to work against the other way."
The June Sapien 3 FDA approval was for patients with aortic valve stenosis who are at high risk for open-heart surgery or who cannot undergo the surgery due to excess risk. But Edwards is looking to move into a less severe, intermediate population. It's expecting one-year Sapien 3 data at year end, with the assumption of positive results as well as an expedited FDA review. Edwards is anticipating a potential intermediate risk approval for Sapien 3 in late 2016.
After that, the transcather mitral valve replacement market may start to come into view for Edwards. Earlier this month, Edwards acquired CardiAQ Valve Technologies for up to $400 million to add to its own transcatheter mitral valve replacement program, Fortis.
Mussallem noted on the call that Edwards is "pleased with the significant progress made by the Fortis program, we were attracted to CardiAQ because of their unique technology, including a differentiated attachment approach and a single valve with multiple delivery systems." The startup already had FDA signoff to do an early feasibility study of it in up to 20 patients, and the device is slated to start a CE-mark study in Europe.
- here is the release and the transcript