Edwards Life Sciences LLC (EW)

[m177]

EW, another guidance hit

Co issues downside guidance for Q3 (Sep), sees Q3 (Sep) revs of $448 mln vs. $476.56 mln Capital IQ Consensus Estimate. This represents a growth rate of approximately 9 percent, or 14 percent excluding the impact of foreign exchange. This compares to the Company's guidance of $465 million to $485 million provided during its second quarter earnings conference call on July 24, 2012. Transcatheter heart valve sales were below expectations for the third quarter, with global sales estimated at $124 million, including U.S. sales of $55 million. "In Europe, austerity measures tempered procedural volumes, resulting in underlying sales comparable to the same period a year ago. In the U.S., we are pleased with the overall progress of the launch, with training of commercial sites continuing as planned and procedural success rates remaining high. However, under the provisions of the National Coverage Decision, there was no reimbursement for inoperable patients without femoral access. A clinical protocol that would allow reimbursement for this sizable group of patients was expected earlier; it is now anticipated in the next several weeks. Additionally, due to the requirement that a full Heart Team be present for every procedure, summer vacations had a more pronounced effect.... Despite the third-quarter sales shortfall, we anticipate a strong rebound in the fourth quarter. The pending FDA approval to expand the indication to treat U.S. high-risk patients with SAPIEN, as well as the recent addition of our larger 29mm valve and a third delivery approach to our clinical trial, will make this therapy available to a considerably broader group of patients. Assuming this FDA approval happens early this quarter, for full-year 2012, we expect to achieve the low end of both our current global THV sales guidance of $550 million to $600 million, and our U.S. THV sales guidance of $240 million to $260 million. We remain enthusiastic about the potential of this transformative technology to improve the lives of many of the patients who suffer from severe aortic stenosis..."