Endologix Sees Higher Q3 Global Revenue; But Cuts FY14 Outlook - Quick Facts

(RTTNews) - Endologix Inc. (ELGX) said that it anticipates third quarter 2014 global revenue of about $37.0 million, representing about 11% growth as compared to $33.3 million for the third quarter 2013. Analysts polled by Thomson Reuters expect the company to report revenues of $37.68 million for the third-quarter. Analysts' estimates typically exclude special items.

The company updated its full year Adjusted net loss per share and EBITDA guidance to reflect the $4.5 million inventory charge and its updated expectations for full year revenue.

The company anticipates U.S. revenue to be approximately $27.0 million in the third quarter 2014, representing approximately 2% growth compared to $26.5 million for the same quarter in 2013. International revenue is anticipated to be approximately $10.0 million in the third quarter 2014, representing approximately 47% growth compared to $6.8 million for the same quarter in 2013.

Endologix also announced the introduction of DURAPLY ePTFE Graft Material for the AFX Endovascular AAA System. DURAPLY is manufactured with an advanced, proprietary ePTFE processing technology that optimizes strength and conformability. As a result, the company will realize an inventory write-off of approximately $4.5 million for existing graft material inventory, or $0.07 per share, in the third quarter 2014.

The company cut its full year 2014 revenue guidance to a range of $145 million to $148 million, from the previous guidance of $148 million to $152 million.

The company said it now expects annual adjusted net loss per share to be in the range of $0.37 to $0.43 per share, compared to previous guidance of loss $0.27 to $0.33 per share.

Negative Adjusted EBITDA for fiscal year 2014 is expected to be $0.20 to $0.26 per share, compared to previous guidance of Negative Adjusted EBITDA of $0.10 to $0.16 per share.

Wall Street currently is looking for fiscal year 2014 a loss of $0.28 per share on annual revenues of $150.96 million.

In a separate press release, Endologix announced that it will conduct the first ever prospective randomized clinical study to compare outcomes in endovascular repair of abdominal aortic aneurysms (EVAR). The LEOPARD Study (Looking at EVAR Outcomes by Primary Analysis of Randomized Data) has been designed to provide an accurate and unbiased assessment of commercially available EVAR devices with a planned enrollment of 600 patients.

LEOPARD will include up to 60 active EVAR centers throughout the United States. The primary endpoint of the study is treatment success at one year based upon: procedural success; and rates of freedom from aneurysm rupture; conversion to open surgical repair; endoleaks; clinically significant device migration; aneurysm enlargement and secondary endovascular procedures. Results from the study will be independently adjudicated by a third-party. The follow-up period will be five years.

Separately, Endologix said that it has completed patient enrollment in the EVAS FORWARD -Global Registry. From October 2013 to September 2014, the registry enrolled 300 patients treated with the Nellix EndoVascular Aneurysm Sealing System at centers in Europe and New Zealand.

Patients enrolled in the EVAS FORWARD - Global Registry will be followed for five years, with a primary endpoint evaluating safety and effectiveness of the Nellix EVAS System at 12 months post procedure. Interim data from the registry is expected to be presented over the course of the five year follow-up period. The next data presentation from the registry is anticipated at the VEITH symposium in November 2014. Dr. Holden is expected to present data from the first 250 patients enrolled in the trial, which will include results at 30-days post procedure or greater.