Total revenue for the company’s high intensity focused ultrasound (HIFU) division was EUR2.0 million ($2.6 million) in the first quarter 2009, compared to EUR2.2 million ($3.4 million) for the same period last year. Total revenue reflected the sale of one Ablatherm-HIFU machine during the first quarter 2009, compared with two in the first quarter of 2008.
Total revenue for the company’s lithotripsy division was EUR3.3 million ($4.3 million) in the first quarter 2009, up 47.8% from EUR2.3 million ($3.4 million) for the same period last year. The increase resulted from higher machine sales, as seven devices, including three Sonolith I-Sys systems were sold during the first quarter 2009, compared to five machines with no Sonolith I-Sys devices sold during the year ago period.
Gross profit for first quarter 2009 was EUR2.1 million ($2.7 million), against EUR2.0 million ($3.0 million) for the first quarter 2008. Gross profit margin was 39.7% in the first quarter of 2009 compared to 44.1% in the first quarter of 2008 primarily based on a year-over-year increase in sales of lower margin lithotripsy equipment.
Operating expenses decreased to EUR3.4 million ($4.4 million) in the first quarter 2009, against EUR3.5 million ($5.3 million) for the same period of 2008. First quarter 2009 operating expenses included EUR0.4 million related to the U.S. FDA ENLIGHT clinical trial for Ablatherm-HIFU. Operating loss was EUR1.3 million ($1.6 million) for the first quarter 2009, compared to EUR1.5 million ($2.4 million) for the year ago period. The year-over-year decrease in operating loss reflected higher lithotripsy machine sales in the first quarter of 2009.
As of March 31, 2009, the company had cash and cash equivalents, including short-term treasury investments, were EUR14.7 million ($19.5 million).
Marc Oczachowski, EDAP’s chief executive officer, commented, “We remain totally committed and focused on moving our HIFU prostate cancer treatment to commercialization in the U.S. We are very pleased that our discussions with the FDA have led to significant protocol changes for the trials which we believe will have a major impact to accelerate enrollment. As I have indicated in the past, we have been disappointed with the pace of trial enrollment which was below our expectation and believe these changes are an important step to rectify this situation. We remain in discussions with the FDA to advance the cryo arm of the study. Our major overall goal is to complete the trials within the targeted time. We are also strengthening our U.S. clinical team to better assist investigators and coordinators in their duties in order to achieve this goal.”
Oczachowski continued, “We are quite pleased as well with the continued progress of our European business operations. Particularly we are encouraged by continued progress across our HIFU business as well as the strength of our lithotripsy division, driven by the continued penetration of our next generation Sonolith I-sys device.”
Oczachowski concluded, “Given the current economic environment, we remain focused on conservatively managing our business, maintaining our cash and reducing costs while improving efficiencies. We are confident that our ample cash position and strong market position will continue to allow EDAP to weather the current volatility.”
