Lee Roth - IR, The Ruth Group Philippe Chauveau - Chairman Marc Oczachowski - Chief Executive Officer Francois Dietsch - Chief Financial Officer

Stanley Mason - Private Investor

Good day and welcome to the EDAP TMS Second Quarter 2015 Earnings Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today’s presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Lee Roth at the Ruth Group. Please go ahead.

Thanks, Andrew, and thanks everyone for joining us today. With me from management are Philippe Chauveau, Chairman of the Board; Marc Oczachowski, Chief Executive Officer; and Francois Dietsch, Chief Financial Officer. Before we begin, I would like to remind everyone that management’s remarks today may contain forward-looking statements, which include statements regarding the company’s growth and expansion plans. Such statements are based on management’s current expectations and are subject to a number of uncertainties and risks that could cause our actual results to differ from those described in such forward-looking statements. The factors that may cause such a difference include, but are not limited to those described in the company’s periodic filings with the U.S. Securities and Exchange Commission. With that, it's now my pleasure to turn the call over to Philippe Chauveau, Chairman of EDAP. Philippe?

Good morning, and welcome to EDAP’s Q2 2015 conference call. I have brief opening remarks to share with you. First in the second quarter we achieved a strong year-over-year revenue growth. We were nearly at breakeven on an operational basis, and we were cash flow positive for the quarter. Second, we achieved these results based on strength from both our HIFU and Lithotripsy divisions with no HIFU sales in the US. And third, we submitted our response to the FDA request well within time allowing them to continue their review of the De Novo petition for Ablatherm. Now, I’ll turn over the call to Marc. Marc?

Thank you, Philippe. Good morning everyone and thank you for joining us on our Q2 2015 earnings call. Overall Q2 was an excellent quarter for us on a number of levels. We reported 39% year-over-year revenue growth based on strengths from both our HIFU and Lithotripsy businesses. This strong second quarter allowed us to get back to growth as we recorded more than 14 million euro revenues total in the first half of 2015, representing 5% growth as compared to the first half of 2014, which was a record year in revenues for EDAP. On another note, the strong Q2 with revenues of 7.9 million euros puts the company in nearly breakeven position. This is an important point as the company is able to achieve almost breakeven, while its HIFU technology is not yet approved in the US. In terms of cash, Q2 was a great quarter and thanks to the strong level of revenues and our careful expense management policy, we ended the quarter cash flow positive, keeping our balance sheet strong and finishing with cash of 11.8 million euros. To summarize, Q2 was a solid quarter with exciting growth. Q2 clearly demonstrated the company’s ability to be close to its breakeven point, even with its most significant growth catalyst still to come. Even if we all know that we need to see numbers on a larger scale than a quarter only, this looks promising to us. Let us review the business achievements and the growth generated in both the HIFU and Lithotripsy divisions. Let us start with the HIFU division, where we recorded 55% year-over-year growth in Q2 2015. During Q2, we sold two new Focal One devices, including our first Focal One in Italy, a country where our Ablatherm HIFU is well-known and widely used. In addition to this device sale, we entered into several pay-per-use contracts with centers in Italy. This is good news and a strong trend to see Italy following the path opened a few months earlier. Other major European countries, including France and Germany, are adopting Focal One as an effective and unique answer to the current trend, which favor the focal approach in the treatment of prostate cancer. The second Focal One device was sold in France to the prestigious MediPôle Partenaires Hospital Group. This is a very innovative group of private hospitals spread throughout France, including world ranked urology teams such as St-Augustin Hospital in Bordeaux where robotic surgery of prostate cancer was pioneered. It is excellent news and provides more real proof that the use of non-invasive and focal technologies, such as HIFU, is becoming a must for world-class institutions treating prostate cancer. In addition to this device sales, we continue experiencing growth in our revenues generated from the use of our devices, including consumables and pay-per-use machines, which began in the first quarter. In Q2 2015, we grew these revenues by 30% as compared with Q2 of last year. This clearly demonstrates the solid growth in the use of HIFU for the treatment of prostate cancer patients mainly in Europe. This trend and growth is a reflection of the change in the market with the evolution of the patient profile, the need for non-invasive technologies and the growing interest in the focal approach. This combined with EDAP’s unique offering with its two HIFU devices, covering most market segments from radical treatment to focal approach and salvage treatments, positions us for continued growth in Europe and elsewhere. As announced via earlier press releases, we recruited top surgical centers in Europe that are now using our Focal One device, including Swiss Centre Hospitalier Universitaire Vaudois in Lausanne, and Geneva University Hospital, and Germany’s famous Martini-Klinik. As a reminder, Martini-Klinik is the largest prostate cancer center in the world, performing over 2000 radical prostatectomy procedures per year. To give you a better idea, this is much more than the US well-known Memorial Sloan-Kettering Cancer Center in New York. We continue to develop and enhance our HIFU sales, marketing and clinical capabilities with the goal of maximizing our installed base of both Ablatherm and Focal One systems and centers. We remain intensely concentrated on driving adoption of our HIFU technology and growing the average number of procedures performed on each of the installed systems around the world. Now let us talk about our other division. In Q2 of 2015, revenues from our Lithotripsy division were up 33% over last year. It is important to note that this growth was achieved thanks to a large number of machines sold, as well as a strong revenue contribution from our product distribution activity in some of our subsidiaries such as those in Japan and France. We continue working systematically on our experienced and well-established network of subsidiaries and distributors to seize as many business opportunities as possible. As mentioned at the beginning of this call, these solid results were achieved without any HIFU related revenue from the US as we continue to work through the regulatory process with our De Novo 510(k) submission. As we stated previously, bringing our HIFU technology to the US via FDA clearance of Ablatherm remains a top priority. On the last call, we discussed our submission of the Direct De Novo 510(k) petition for Ablatherm HIFU based on the tool claim with an indication of prostatic tissue ablation. EDAP submitted its De Novo petition to the FDA at the beginning of quarter two during the month of April. As also announced in July, we received a feedback letter from the FDA containing a list of deficiencies and questions as per the standard FDA protocol and timing for the De Novo 510(k). This list outlines items and topics for which the FDA has requested additional information or further clarification to continue its ongoing review. As we stated at the time, we were pleased to see that only four points were raised in the deficiency list with the FDA requesting first the results of a reprocessing validation test, additional information regarding our physician training program, additions and modifications to the draft labeling materials, and additions and modifications to the draft user manual. As announced earlier this week, we submitted our complete and formal response to all the items on the deficiency list. Our team was able to address these items quickly and efficiently as expected. As the reprocessing validation test, we are already underway when we received the letter. They were completed in a timely manner and all passed. While these tests were being completed we were able to compile the additional information of a physician training program and address the FDA’s requested additions and modifications to our draft labeling materials and user manual. The FDA review of our De Novo petition for Ablatherm HIFU as in practice was put on hold when the letter was issued, and our submission of the response has allowed them to resume their review of the materials, which also means the clock is back on. As you may know, the De Novo 510(k) typically involves 120 days of active review. At the time of the deficiency letter, we were approximately halfway through that 120-day period. It is also important to note that there is no formal obligation for the agency to comply with this timing and it is actually used more as a guideline than anything else. Also it is possible that the process could be placed on hold again if the FDA requires any additional information or classification as part of the ongoing review. Having said that, we are pleased with how smoothly the process has gone this far and plan to continue to work closely with the FDA to advance the process further. In summary, the second quarter of 2015 was an important period for EDAP, and we are well positioned to continue advancing in the second half of the year. We achieved strong top line growth across both segments of our business. We strengthened our cash position to 11.8 million euros, and we received FDA feedback to our De Novo 510(k) petition and were able to quickly provide a complete formal response. Finally, and as we announced last month, Eric Soyer has resigned from EDAP to accept a senior executive position at a publicly traded French biotech company, and we have promoted Francois Dietsch from Group Financial Control Manager and Finance Manager of the French subsidiary to CFO. With that, I will then turn the call over to Francois to review our financial results.

Thank you, Marc, and good morning, everyone. I will first take a few minutes to review our financial results for our Q2 2015. Total revenue for Q2 2015 was 7.8 million euro or $8.7 million, compared to 5.6 million euro or $7.7 million for the same quarter of 2014. As Mark already mentioned, the 39% growth in this three month period resulted from both HIFU and Litho businesses. Also for the second quarter 2015, gross profit was 3.3 million euros or $3.7 million, compared to 1.8 million euros or $2.5 million for the year ago period. Gross profit margin on net sales was 42.5% compared to 32% in the year ago period. Operating loss in Q2 was 0.2 million euros or $0.2 million, compared to an operating loss of 1.6 million euros or $2.2 million in the second quarter of 2014. Finally for Q2, EDAP recorded a positive net income of 0.5 million euros or $0.5 million, or 0.02 euro per diluted share, as compared to a net loss for our Q2 2014 of 5.3 million euros or $7.2 million, or 0.23 euro per diluted share. Net income in Q2 2015 included a non-cash interest income of 1.0 million euros to adjust the accounting fair value of the outstanding warrants. This completes my second quarter 2015 comments. Now turning to the first six months of 2015, total revenue was 14.1 million euro or $15.6 million, up 4.9% compared to 13.4 million euro or $18 million for the first half of 2014, which is a record high for the period. Gross profit for the first six months of 2015 was 5.9 million euros or $6.6 million, and gross profit margin on net sales was 42.1% compared to 40.1% in the year ago period. Operating loss for the first six months of 2015 was 0.8 million euros or $0.9 million, which is a 0.2 million euros reduction with the same period last year. Including a non-cash interest expense of 1.3 million euros to adjust outstanding warrants to fair value, net loss for the first six months of 2015 was 2 million euros or $2.2 million or 0.08 euro per diluted share. This compares to the first six months of 2014 net loss of 4.4 million euros or $5.9 million or 0.20 euros per diluted share. Finally and most importantly, as of June 30, 2015, cash and cash equivalents, including short-term treasury investments, were 11.8 million euros or $13.2 million. As Marc noted, we were cash flow positive for the second quarter. With that I will turn the call over to the operator who will open the line for questions. Operator?

[Operator Instructions] The first question comes from Stanley Mason, a Private Investor. Please go ahead.

Good morning. I have a question with regards to revenue from procedures, in the first quarter it appeared that most of the revenue was coming from Germany, and I’m wondering whether now we are getting some revenue from France because they have approved reimbursement, whether we are getting any revenue from Canada, and also Switzerland, could you comment on that please?

Well, I mean, in the revenue per procedure, even in the first quarter we generated – the two major countries generating revenue per procedure are Germany and France, and also Italy. So that was the case in Q1 as well, and we get also, as you mentioned, revenue per procedure from other areas including Canada. This being said and you are absolutely right, we’re really seeing an increase in revenue per procedure this year in France thanks to the start of execution of the reimbursement. So that is definitely helping the hospital to use more HIFU as they are getting reimbursed.

Excellent. Thank you very much and once again I wish you well. I am firm believer in HIFU, I’ve had it, and I wish you the most success. Thank you very much.

Thanks Stanley.

[Operator Instructions] This concludes our question-and-answer session. I would like to turn the conference back over to management for any closing remarks.

This is Philippe Chauveau, the Chairman. There being no further questions, I will now close this conference call. Thank you everyone for participating in today’s call. Thank you and goodbye.

The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.