AGA Medical Reports 2010 Third Quarter Financial Results

AGA Medical Holdings, Inc. (AGA Medical) (NASDAQ: AGAM), a leading developer of interventional medical devices for the minimally invasive treatment of structural heart defects and vascular abnormalities, today reported financial results for the third quarter ended September 30, 2010.

Highlights of the Third Quarter of 2010 include:

• The addition of left atrial appendage closure to an existing G-DRG (German Diagnosis Related Group) reimbursement code in the 2011 G-DRG Catalog which will be applicable to the company’s Amplatzer ^® Cardiac Plug; and
• Continued enrollment in its U.S. RESPECT clinical trial, designed to evaluate the link between a patent foramen ovale (PFO) and cryptogenic stroke, with 807 patients enrolled in the study and 1,639 patient follow-up years as of October 31, 2010.

Financial Results for Third Quarter 2010 vs. Third Quarter 2009

Net sales for the third quarter of 2010 were $50.5 million, a 0.6% increase over $50.2 million for the third quarter of 2009. On a constant currency basis, net sales grew 4.3% year over year. Sales growth from the prior year quarter was negatively impacted by several items including the significant impact of currency, the delay in receiving FDA clearance for our Amplatzer Vascular Plug 4 and the temporary inability to import and sell products into India. This was resolved in early October and the company has since resumed shipments. The company also experienced a continued delay in the issuance of a significant government tender in a Latin American country.

Gross margins for the third quarter of 2010 were 86.6% (86.9% on a constant currency basis) compared to 86.8% in the prior year period.

Total operating expenses for the third quarter of 2010 were $39.6 million as compared to $38.6 million in the third quarter of 2009. Total operating expenses for the third quarter of 2010 were lower than in the second quarter of 2010, at $39.6 million versus $40.6 million, respectively.