Endologix (ELGX) Tops Q2 EPS by 7c, Bumps Outlook

Endologix (NASDAQ: ELGX) reported Q2 EPS of ($0.13), $0.07 better than the analyst estimate of ($0.20). Revenue for the quarter came in at $51 million versus the consensus estimate of $46.3 million.

John McDermott, Endologix Chairman and Chief Executive Officer, said, “We continue to deliver solid revenue growth above expectations and are very pleased with the TriVascular mergerintegration. Our revenue performance in the second quarter was driven by strong growth with Nellix in international markets, including the launch of our next generation system in Europe, and the full market release of AFX2 in the U.S. For Nellix, we reported several positive clinical data updates during the quarter, highlighted by the results from the EVAS FORWARD-IDE study. These data featured significantly lower rates of endoleaks and secondary interventions with Nellix, which further increases our confidence in its long-term potential to be a market leading device in the treatment of AAA.”

Mr. McDermott continued, “In July, we completed our 100-day PMA meeting with the FDA and remain confident in the approvability of Nellix. The FDA has requested additional information related to our PMA submission and also indicated that we might need to go to an Advisory Committee Panel given the novelty of EVAS compared to traditional EVAR. If we do not have to go to panel, we still believe it’s possible to receive PMA approval in the first quarter of 2017. If we do have to go to panel, we believe that it pushes out the potential PMA approval into the third quarter of 2017. We are working very collaboratively with the FDA to provide the required information and remain confident in the PMA approval of Nellix based upon the IDE clinical results, data from other international studies and our worldwide experience which now includes over 6,000 patients.”

GUIDANCE:

Endologix sees FY2016 revenue of $197-203 million, versus prior guidance of $192-202 million and the consensus of $198.2 million.

For earnings history and earnings-related data on Endologix (ELGX) click here.

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