Edap Tms SA (ADR) (Nasdaq:EDAP), the global leader in therapeutic ultrasound, announced financial results for the fourth quarter and year ended December 31, 2014, and provided an update on recent strategic developments.

Marc Oczachowski, EDAP's Chief Executive Officer, stated, "We are very pleased by our 2014 global revenue and the 11% growth over 2013, driven by a 70% increase in revenues from the HIFU division. This solid year-over-year growth in HIFU revenues is a reflection of the growing acceptance and recognition of our HIFU technology worldwide for the non-invasive treatment of prostate cancer. We also benefited from the early adoption of our recently launched Focal One device. We continue to experience growing interest in the focal approach of prostate cancer treatment, which complements our Ablatherm HIFU, giving us a unique and comprehensive HIFU offering for the global market.

"We are particularly pleased with the performance of Focal One, as we sold six systems in 2014 compared to one in the prior year. In the first quarter of 2015, we brought this next-generation technology to North America following clearance of the device by Health Canada. I am proud to say that we closed our first Focal One sale, to Montreal Jewish General Hospital, just two months after receiving regulatory clearance in January."

Mr. Oczachowski added, "Foremost among our accomplishments was a recent FDA meeting, at which they recommended we seek clearance of Ablatherm HIFU via a Direct De Novo 510(k) petition. This is encouraging news and a huge opportunity, as we believe it may accelerate the commercialization of our technology in the US."

Fourth Quarter 2014 Results

Total revenue for the fourth quarter 2014 was EUR 6.5 million (USD 8.0 million), compared to EUR 8.1 million (USD 11.0 million) for the fourth quarter 2013.

Total revenue for the HIFU division was EUR 1.0 million (USD 1.3 million) for the fourth quarter 2014, compared to EUR 1.5 million (USD 2.1 million) for the same period last year.

For the three months ended December 31, 2014, total revenue for the lithotripsy division was EUR 5.5 million (USD 6.7 million), compared to EUR 6.6 million (USD 8.9 million), during the year ago period. During the fourth quarter 2014, the Company recorded sales of 14 lithotripsy machines, comprised of 12 Sonolith i-move devices and two Sonolith i-sys devices, which compares to a total of 18 devices sold in the fourth quarter of 2013.

Gross profit for the fourth quarter 2014 was EUR 2.4 million (USD 3.0 million), compared to EUR 3.3 million (USD 4.4 million) for the year ago period. Gross profit margin on net sales was 37.3% in the fourth quarter of 2014, compared to 40.1% in the year ago period.

Operating expenses were EUR 3.5 million (USD 4.3 million) for the fourth quarter 2014, compared to EUR 3.0 million (USD 4.1 million) for the same period in 2013.

Operating loss for the fourth quarter was EUR 1.0 million (USD 1.3 million), compared with operating income in the fourth quarter of 2013 of EUR 226,000 (USD 309,000).

Net loss for the fourth quarter 2014 was EUR 2.6 million (USD 3.3 million), or EUR 0.11 per diluted share, as compared to EUR 570,000 (USD 778,000), or EUR 0.03 per diluted share, in the year ago period. Net loss in the fourth quarter 2014 included a non-cash interest expense of EUR 1.2 million to adjust the accounting fair value of the outstanding warrants.

Full-year 2014 Financial Results

Total revenue for the twelve months ended December 31, 2014 was EUR 26.8 million (USD 35.4 million), up 11.2% compared to EUR 24.1 million (USD 32.0 million) in 2013.

Total revenue for the HIFU division was EUR 8.7 million (USD 11.5 million) for 2014, compared to EUR 5.1 million (USD 6.8 million) in 2013, a year-over-year increase of 70.0%.

Lithotripsy division revenue was EUR 18.1 million (USD 23.9 million), compared to EUR 19.0 million (USD 25.2 million) in 2013.

Gross profit for the year was EUR 11.2 million (USD 14.8 million), with gross profit margin on net sales of 40.6%, compared to 38.7% a year ago.

Operating loss was EUR 1.7 million (USD 2.3 million), an improvement of EUR 1.0 million over operating loss of EUR 2.8 million (USD 3.7 million) in 2013. Operating loss for the year 2014 included FDA-related costs of EUR 1.2 million (USD 1.6 million).

Full-year net loss was EUR 512,000 (USD 676,000), or EUR 0.02 per diluted share, as compared to net loss of EUR 5.0 million (USD 6.7 million), or EUR 0.24 per diluted share, in 2013. Net loss in the full year 2014 included non-cash interest income of EUR 1.8 million to adjust the accounting fair value of the outstanding warrants.

At December 31, 2014, cash and cash equivalents, including short-term treasury investments, were EUR 12.1 million (USD 14.7 million). (Original Source)

Shares of EDAP closed today at $3.6, down $0.03 or 0.83%. EDAP has a 1-year high of $6.05 and a 1-year low of $1.15. The stock's 50-day moving average is $3.65 and it's 200-day moving average is $2.45.

EDAP TMS SA develops, produces and markets minimally invasive medical devices, mainly for urological diseases. Its activity is organized in two divisions: HIFU and UDS.