Good day. And welcome to the EDAP TMS Second Quarter Earnings Conference Call and Webcast. All participants will be in listen-only mode. Should you need assistant please signal our conference specialist by pressing the star key followed by zero. 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 Carol Ruth. Please go ahead.

Thank you, operator. With us today from management are Philippe Chauveau, Chairman of the Board; Marc Oczachowski, Chief Executive Officer; and Eric Soyer, Chief Financial Officer. Before we begin, I'd like to remind everyone that management's remarks today may contain forward-looking statements. These 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 actual results to differ from those described in these forward-looking statements. Factors that may cause such a difference include, but are not limited to, those described in the company's filings with the Securities and Exchange Commission. Now, I'd like to turn the call over to Mr. Philippe Chauveau. Philippe?

Good morning, everyone. And thank you for joining us on our second quarter 2014 investor conference call. I have three opening highlights to share with you. First, our high growth international performance particularly for Ablatherm HIFU. Second, our satisfactory operational results in the first six months of 2014 added to a strong backlog in Q3. And third, our solid cash management with only EUR 900,000 that's less than EUR 1 million cash net utilization in the last 12 months. Now I'll turn over the call to Marc. Marc?

Thank you, Philippe. And thank you all for joining us for our second quarter 2014 conference call. I will review recent developments across our business segments and then I'll turn the call over to Eric to discuss the financial results for the quarter. Following Eric's comments, we will open the line for any questions you may have. Before providing the business update and quarterly results, I would like to discuss the recent FDA advisory committee meeting for Ablatherm HIFU. As we have previously stated we are disappointed with the recommendation from the panel. However, it is important to remember that this is only part of the approval process and the recommendation made by the panel is not binding, and does not reflect the FDA's final decision. Now that the panel has met and voted, the FDA review team will regroup, analyze and surgeon comments they gathered during the meeting and continue its review process as they work towards a final decision. In other words, the process is not over and we at EDAP are continuing our interaction and dialogue with the FDA review team in order to provide them with all needed and required information. We are particularly frustrated that the panel was not able to provide neither an answer nor any guidance on the possible and acceptable test for new device for the treatment of low -risk prostate cancer. A similar scenario occurred in the 2009 panel on prostate cancer and in the workshop the FDA organized during the American Urology Association annual meeting in 2013. Also, it is a fact that none of the currently available therapies for prostate cancer in the United States including a robotic surgery and radiation therapies were subject to the same regulatory test as HIFU. Based on the level of requirements and the…

Thank you, Marc. And good morning everyone. I will now take a few minutes to review financial results for the three and six months periods ended June 30, 2014. Total revenue for the second quarter 2014 was EUR 5.6 million or $7.7 million, a 25% year-over-year increase compared to EUR 4.5 million or $5.9 million for the second quarter 2013. Total revenue for the HIFU division was EUR 1.5 million or $2 million for the second quarter 2014 compared to EUR 967,000 or $1.3 million for the same period last year. The company recorded the sale of one Ablatherm HIFU device and one Focal One device in the second quarter 2014. Total revenue for the lithotripsy division was EUR 4.1 million or $5.6 million for the second quarter of 2014, an increase of EUR 3.5 million or $4.6 million during the year ago period. During the second quarter 2014, the company recorded sales of 12 lithotripsy machines, comprised of eight Sonolith i-move devices, two Sonolith i-sys device, and two Sonolith Praktis device, compared to a total of 8 lithotripsy devices sold in the second quarter of 2013. Gross profit for the second quarter 2014 was EUR 1.8 million or $2.5 million, compared to EUR 1.6 million or $2.1 million for the year-ago period. Gross profit margin was 32% in the second quarter 2014, compared to 36% in the year-ago period. Operating expenses were EUR 3.4 million or $4.7 million for the second quarter 2014, compared to EUR 3.1 million $4.0 million for the same period last year. Operating loss was EUR 1.6 million or $2.2 million for the second quarter of 2014 compared to EUR 1.5 million or $1.9 million in the second quarter of 2013. Net loss for the second quarter 2014 was EUR 5.3 million or $7.2 million…

(Operator Instructions) And the first question is from Suraj Kalia from Northland Securities. Please go ahead.

Good morning, Marc and Eric. So, Eric, let me start out with you and then I have a couple of questions for Marc. Forgive me if I miss this Eric, did you give the backlog of Ablatherm and the Sonolith or the litho machines in the quarter?

The backlog for Q3 is two HIFU machines and 10 lithotripsy machines.

10 litho, fair enough. So Marc, you know we were all disappointed with the FDA panel vote and I think so your commentary specifically around other competing technologies being aggressively used in prostate cancer without having to go through the rigor that you have all been exposed to, I think so it rings absolutely true. And I think so all of us recognize that. Having said that Marc, I think so we are in a bind right now and I am curious -- I loved for -- you too shed some color and help us to reconcile specifically your commentary about Europe where rightfully so HIFU is being aggressively used for low-risk prostate cancer. But Marc, the 10 year data, the papers that was published, my understanding was that was a part of your PMA submission and the panel did look at that. So can you help me reconcile the apparent use in Europe but then the panel sort of looking the other way?

Well, this is a complicated thing indeed. And what I said is that I think the results and the capacity of HIFU to treat prostate cancer and the result we've got in Europe and that's why we published the review into review publication on the questions. I think the main question was about how to prospectively and statistically do a comparison for two treatment options for low-risk patient without having something that is not feasible. Now in most of the randomized trials that have been tried to do so were selling and either they were not --they were taking more than 20 or 25 years like the Swedish study. So that was mainly the discussion and the issue was to evaluate the -- I would say theoretical way something that the panel also agree that it was kind of probably not evaluable.

Okay. And Marc, I think so couple of time stressed the point that FDA is still actively reviewing your PMA submission. Based on your internal analysis, Marc, I think so I am very curious to get some color on especially given the 9-0 vote against efficacy. How do you see a potential pathway, especially after the panel vote? I am curious you are all seeing something with the FDA or what kind of communication are you having that gives you all some glimmer of hope?

Sure, well, as we are in very actively session right now with the FDA and working very closely with them. I will not go into too much detail. Let me get back on the 9-0 vote for efficacy. That was mainly based on the fact that again if you want to compare efficacy at x years between a treatment and watchful willing or active surveillance for low-risk prostate cancer, that's again something that was tried in the keep up study, the keep up sale because they couldn't recruit the number of patients for many obvious reasons. And basically the study of the result on the few patients they got was not giving a significant difference. Same for the Swedish, for the Swedish study to compare the efficacy of like prostatectomy on the low-risk patient again active surveillance. Again after 25 years the statistical difference was difficult to see. So exactly I think the reason why we've got bad vote in efficacy because basically today there is neither clinical study design nor an agreed endpoint to satisfactory or to auto measure the proper way with satisfaction, the effectiveness of any technology for the treatment of low-risk prostate cancer. And Dr. Octavio said that to do so it may take probably 25 years, the comparative would be active surveillance end point we are not completely sure what would it be but it would certainly take more than 20 years which is a cycle of life for technology so it doesn't make sense. We have obligation to answer your questions, we are in discussion with the FDA and again at this stage we cannot further comment or disclose the different options and discussions we are having.

So that's fair enough. So Marc, if hypothetically the FDA comes back and says, guys, here is the CRL and we cannot give you approval at this time, but come back to us with the new design or if you guys do a new trial we would consider it. I guess I am curious and I'll hop back in queue after this question, given that the guidance from the FDA as my understanding is, has been relatively mixed in the past, and it seems like you are all been strung out for so many years -- question number one I guess would you guys consider giving new trials even if that is a definitive structure end point prospectively defined end point that the FDA provides you financially as well as for risk perspective would you consider it? Love to get your color on that.

Well, it's -- I understand your question. But I would say it's probably early to answer that question. We are now focusing on the next step for the process working with the FDA so and there will be a number of different possible questions or answers or decisions from the FDA on the current file. And they could be also having a number of different options after they make a decision depending on what is the decision. So I think it's too early and they have too many efficacies there.

The next question comes from George Zavoico of MLV and Co. Please go ahead

Hi, good morning, thank you very much Marc for that review of the FDA outcome meeting. I have a follow up question and I fully understand the restrictions you have with regard to what you can say about ongoing discussions. So I am kind of presenting sort of as a hypothetical question. If the option of or one alterative outcome as it were a conditional approval with some still to be disclosed follow on studies that might need to be done? Would this be perhaps one possible scenario?

Again there is lots of different scenario available today. And that's in the hand of the FDA and today we are working with them on the next steps. And again keeping on answering their questions and comment so I can't in terms of the -- on the behalf of the FDA the other question.

Okay. And is there any timeline, is there --that the FDA must adhere to after an outcome PDUFA or that sort of thing?

I mean as usual the time control is in the hand of FDA and is not been given any timeframe or timeline.

Okay, thanks for that. And my final question congratulation on the growth of the lithotripsy division. I mean you've always -- well maybe not always but you've often said that you are looking for the growth to come mainly from the HIFU and Ablatherm division. But your lithotripsy division used to be running along quite well. Could you comment on perhaps what you see in the future in that division? Can you sustain that growth going forward or is this perhaps a little bit of outlier or seasonal effect?

Well, I mean we don't-- I mean that you know we don't give too much of following statement on that. But I think the good results in our division, HIFU and lithotripsy and particularly as you said in lithotripsy was -- it is a very competitive and mature market. I mean our continued growth in the division and market segment really shows the EDAP's capability of innovation and market penetration. So this is our sales and marketing strategy as we move forward we want to continue bringing innovation to the urology for the treatment for kidney stone and prostate cancer. So we do and we see that people are getting affected by that. And again growing our interest of investment taking share from the competition and we are continuing to do so and we will continue.

That's terrific. And you mentioned innovation and you also mentioned in the last response of technological lifecycle of about 25 years. Your selling devices that are fairly new but I would imagine your R&D process and work still continuing. Do you envision in the next couple of years coming out with a new device, in your HIFU device or new lithotripsy device or would you just mainly to serve incremental technological improvements?

Well, again I won't -- I mean for obvious reason and competitive reasons disclose any of our product program. But if you look back in the urology field, we probably are the only company that has continuously renewed its range of (inaudible) but also got some new devices as we launch last year Focal One device. I mean we almost every year get a new device on the market only for to share process and enter applications and this is I think quite unique and this is also what is making EDAP probably the most innovative company in the field. And that's again part of our strategy.

Our next question comes from John Harold from Harold and Associates. Please go ahead.

Yes. It seems like the company was very unprepared for this FDA panel hearing. And with the 9-0 vote on efficacy, do you think this is going to affect the opinions of probable potential customers in Europe?

Sorry, I didn't get your point.

Well, do you think that the FDA panel vote is going affect the purchase of European customers? Do you think they look at for data and say, well; maybe this isn't what we want. And --

Well, I mean I don't know and we see that what I know is that what's happening in Europe today is quite different from where we are here in the U.S. even at the investigation point of this FDA filing in the FDA, PMA is for world examination using others and HIFU on low-risk prostate cancer when Europe as I mentioned earlier today and rest of the world are already very turned to the focal approach of prostate cancer which make -- which look to make a lot of sense in the segment of that disease as the disease is evolving. So in Europe, they are already using HIFU and they are probably already at the next level. So it is difficult to compare the study design and the result and the concerns from the FDA or from the panel at least to what's happening in Europe. So we will see how it goes but again I am confident and again we can see how big growth has been in the first half of the year and that's mainly thanks to again the launch of our additional and new HIFU device dedicated to the focal treatment of prostate cancer that is Focal One. And again that most of the luminary centers and robotic surgery centers are really where you are waiting and jumping on them.

And based on your $17.5 million cash position and your CapEx maybe going forward, how long do you think that cash will last you?

I will leave it to Eric.

Yes, well, again we will not give any projections or forward looking statements at least on the term. In our financial comments we explained that our cash utilization in the last 12 months was less than EUR 1 million, so that's why we are able to say that today's cash position is quite solid and robust.

And are you offering any earnings per share guidance for Q3?

Well, no, I mean except the fact that we provided you with our backlog, I mean that's what the orders we received, the order we received until today, so it's standing to see that we have closing in hand and two focal devices.

Our next question comes from Mark Windering of MGW and Associates. Please go ahead.

Hi, gentlemen. I've got a couple of questions. I guess the primary question that I've got is, are you confident going forward that you are going to be able to sustain the company without the need of raising additional capital? Which obviously will become more problematic given what has occurred here recently with the stock price?

Well, on the short term, I think yes but again as usual we won't give any forward looking statement in that sense. And I have no further comments on that as we disclosed today on our conference call and press release.

Okay. So I guess that I am leading to scan current shareholders be relatively comfortable that there would not be any additional dilution in the near future?

That's your conclusion and again Mark I won't comment further on that.

The next question is coming from Peter Cardillo from Rockwell Global. Please go ahead.

Yes, good morning, gentlemen. I just want to touch back on the suits that you have. Did I hear correctly that you do have insurance?

Yes.

I see. Well, why hasn't management come out and put a press release regarding that? I think that would have helped ease some of these concerns even though I believe the issues are frivolous and meaningless, but nevertheless I think that management should be more -- should communicate with the market voice.

All right. I mean I understand your point. But that's insurance like most of companies like ours have and we've been having that since many, many years.

Our next question comes from Terry Carlton a private investor. Please go ahead. \

Yes, good morning, gentlemen. I've got a couple of questions and comments. One, along the line of tax to approval, U.S. HIFU with their competing insolubly HIFU device will be undergoing a similar FDA panel review in October 2014. If it is recommended and approved, will that able to recent met the Ablatherm device using the 501, 510 (k) approach using a liking trend method of approval.

All right. Yes, I mean the Ablatherm device we go on a panel meeting in October indeed, which again it's a panel meeting not a meeting where the FDA makes a decision. And then to answer your question, approval process in the U.S. by the FDA is based on the device and the HIFU device was for treatment of prostate cancer are classified under Plus 3 and Plus 3 product are required to undergo PMA process. Whatever has happened to any of other similar products. So basically the answer as I always said on that question is no. It is not possible for any product to jump on to 510 (k) process, if a similar product is approved. Again until at least the classification has changed from Plus 3 to Plus 2, Plus 2 our product that could done under 510(k). So the answer is to your question is no.

I am not familiar with the classification differences. Can you explain the difference between the two and three?

Yes. I mean product that are in Plus 2 are eligible for 510(k) because usually they are lot of predicate and comparable delays in technologies on the market for years. And products that are usually quite new with no equivalent on the market for a period of time are usually Plus 3, and either has to do a PMA including a U.S. chemical platform.

Okay. Regarding marketing your device globally, I am curious if you would consider direct marketing to potential patients as opposed to our medical device meeting urology meetings around the world as at least the parallel approach to drive demand for your device. Is this something you are considering?

Well, that's not something that we do too much today and at least outside the U.S., since we are not yet in the U.S. for HIFU because it's not -- I mean outside of U.S. I think it's probably not as recognized as here in the U.S. in terms of patient organization and meetings. But we do have relation in the major countries in Europe with patient association group and we promote our medical solutions and options to those groups. But the main and major marketing actions are throughout the urology the users.

Great. Well, I think it would be good to consider that parallel marketing passage to drive demand from the user or the patient perspective because as I understand the vast majority of people in the United States are still not familiar with HIFU treatment for prostate cancer. So advertisements in major publications could help drive demand.

Definitely

Another comment I have in April 2012 you engaged Greenleaf's help to provide strategic guidance for your FDA submittal. What responsibility did Greenleaf have in validating your testing statistics?

Well, we-- I mean Greenleaf was sought for team to work on the PMA project indeed and but it was more on a strategic advisor type of things and more on strategies. We were reason unsound but it is.

Right. So they won't calling through the numbers and giving you any feedback regarding the validity of all these statistics from the testing?

Well, no, we had a limited consulting agreement with Greenleaf and again it was more to work on strategies and options of this test with FDA.

(Operator Instructions) Our next question comes from Ranjit Wali from RK Small Caps. Please go ahead.

Yes, I was wanting to follow up and see if there is any thought towards reducing the cash drain on the company and as such moving it more towards cash positive and profit status rather than the current status to -- and abandoning a very expensive FDA process and potentially licensing the technology to a larger company at Siemens or the like to take on that endeavor and then just focus on the rest of the world and focus on the potential for HIFU on lung cancer and other uses. Is there any thought towards that?

Again, I think if there were any thoughts we wouldn't further comment on that. And again the process that we've engaged a few years ago with the FDA for Ablatherm HIFU is reaching and is close to the end. Again as I said earlier, it is again another order and we are continuing to work with the FDA. And as they said in several communication with us since the panel review is undergoing nicely so we are at the end and once we will able to get final decisions and then we will see what can be the options for the company depending on the decision.

Absolutely. Just -- that makes good sense. I mean you are at the last miles, I mean that you invested the time and effort up to this point, but in my experience a lot of companies lose their way in and the only companies that survive the long term are profitable companies. I know biotech and medical tech have -- there is more of investor patience would that -- but you obviously have a proven product and that's what it gets through the FDA but alternatively it would be nice to have a backup option where the company could be run profitably in the long haul because obviously this technology is life saving for thousands of people and potentially millions of people so--

Our next question comes from Stanley Besent of Private Investor. Please go ahead.

Good morning, Marc. My question is you plan to now approve for reimbursement and I wanted to know in the last quarter, how many procedures have been performed and planned with reimbursement.

Well, this has been approved for reimbursement in France. But again as you know all administration takes time between approval and execution. So we expect to -- because it is -- I mean two things has to be quick on place with the administration across 2014, so we expect that the reimbursement will be effective and in institution in France starting probably by the end of this year or early next year.

Okay. And how many of facilities in France have the Ablatherm?

So we have approximately 42 to 45 facilities that are access to Ablatherm.

I think that ends my question, and thank you and I had HIFU myself and it is the procedure that should be approved and should be approved in the U.S. And I am really disappointed in the FDA

I understand, thank you for that.

Our next question comes from RK Ramakanth from Wainwright. Please go ahead.

Good morning, gentlemen. What's the price differential between a Focal One device to term device? Probably cannot give me exact numbers, but I want to know at least qualitatively what's the differential there?

You mean in terms of price between Focal One and other term?

Yes.

Well, there is a difference in price as there are differences technically and technologically as one of the main difference, and I don't -- I won't go into a complete product description but one of the main difference between both devices is that Focal One integrate the capability of [Technical Difficulty] featuring MRI images and - can you hear me?

Yes, now I can.

What I was saying is that Focal One device was integrating MRI fusion capabilities that's Ablatherm HIFU does not. So that's one of the major differences and that's making as you will understand the price of Focal One higher than Ablatherm.

Okay. And now that you have French reimbursement approval and also inclusion in the European guideline, how is it helping in marketing the device in the EU and other countries where you can -- where they do recognize the EU guideline?

Well, again, it's another and further expectation of the technology officially speaking and therefore if you need a helpful in the promotion of the technology.

Okay, then the last question is the lithotripsy business continues to do well. And one of your strategies for this year and for the future was to grow the lithotripsy business through geographic expansion. What progress has been made in that front and any commentary towards that?

So I didn't get your point. Could you repeat the question, please?

In terms of developing the lithotripsy business through geographic expansion, where is -- what commentary can you provide us on that front?

That this is something we continue even though the world is quite clutter now but we continue to get into new territories and countries and this is together and combined with again bringing new technical specification and innovation on the devices so I mean that's what we continue to do.

This concludes our question-and-answer session. I would like to turn the conference over to Philippe Chauveau for any closing remarks.

There are being no further questions, I will now close this conference call. And thank you everyone for participating on today's call. Thank you and good bye.