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EDAP TMS S.A. (NASDAQ:EDAP)

Q2 2014 Earnings Conference Call

August 28, 2014 8:30 AM ET

Executives

Carol Ruth- IR

Philippe Chauveau - Chairman

Marc Oczachowski - CEO

Eric Soyer - CFO

Analysts

Suraj Kalia - Northland Securities

George Zavoico - MLV and Co

John Harold - Harold and Associates

Mark Windering- MGW and Associates

Peter Cardillo - Rockwell Global capital

Terry Calrton - Private Investor

Ranjit Wali - RK Small Caps

Stanley Besent - Private Investor

RK Ramakanth - H C Wainwright

Operator

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.

Carol Ruth

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?

Philippe Chauveau

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?

Marc Oczachowski

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 current applicable test for new or additional technology to treat low-risk prostate cancer, it is very likely that none of the existing technologies would qualify for positive vote. The panel voted negatively on the assessment of safety and effectiveness of Ablatherm HIFU device, and we understand that this vote was primarily based statistical design and issued in analyzing members. It is important to note that while the recommendation is not in a favor other than HIFU is a technology and a device that has, we believe, proven to be safe and effective. Indeed, this device has been routinely used around the world for the past 15 years. And has treated more than 40,000 patients. It has approval in Europe via the CE Mark but also in countries where they run their own and specific regulatory program such as Canada, Brazil, Mexico, Russia, South Korea and others. It is important to note that during this 15 years and exactly nine years for the other firm integrating imaging version, which is a device included in our PMA submission, we have not received any type of prescription to the use of our technology. I believe that if Ablatherm HIFU was unsafe, it would not been used presently or it would have been declared to be unsafe in one of the countries in which it is currently approved and used. While there might be cases in which unsafe devices has been in use for few years, we believe 15 years is certainly enough time to goes in safety and effectiveness of a device. In addition, we believe urologists in these markets would not continue to utilize this device to treat patients after so many years if they had safety concerns or question its efficacy. They certainly would have tried it the ban, they would have stopped using it if it would not provide any benefit to their patients. As we reported today, we've seen 104% growth in our HIFU revenues during the first six months of 2014 over 2013. Would that be the case with an unsafe and non effective device? I don't believe so. A non effective and unsafe device for the treatment of prostate cancer might have a chance on three, four maybe five years and a few 100 patients, but would not be kept active in a 15 years career with more than 40,000 treatments performed with approximately 4,000 cases treated in the last 12 months, if it is not a good risk benefit ratio for both patients and urologists. In addition, HIFU received EU improved guidelines in 2014 and reimbursement similar to surgery in France after more than 10 years of clinical data was reviewed which we believe is even further validation of this technology. While we appreciate the panel taking the time to meet, this negative vote was made after only one day meeting. We still believe that the data regarding the safety and effectiveness of Ablatherm HIFU is very compelling. We believe that the treatment of prostate cancer patients including low-risk patients over the past 15 years will have to be considered by the FDA in their review process. And certainly cannot be ignored before making a final decision on whether they will exclude the American patients from this proven therapeutic option for the treatment of low-risk prostate cancer.

To conclude on this, we are continuing to work closely with the FDA. We will, as always, stay at their disposable to answer any additional questions and wrest on to comments they have as they are moving forward in their review to our profile. The advisory panel was only starting the process and as per the agency quote, the review is ongoing and active. Which can be translated as the game is not over and there is still some work to be done before reaching the final decision.

I would also like to briefly address the civil lawsuit that has been field against EDAP, Eric and myself which I am sure some of you are already familiar with. We have the D&O insurance in place and we strongly deny any allegation of wrongdoing and we will vigorously defend against such lawsuits. Since this is ongoing litigation, we are not in a position to provide you with more comments at this stage, and I am sure you can appreciate.

Turning now to our business review and achievements during the second quarter and first half of 2014. We are very pleased with a solid growth of our global revenues of 28% in the first six months. This growth come from a very strong and consistent business outside of the U.S. and was mainly driven by a strong increase in our HIFU revenues. We sold two HIFU devices during Q2, the first one being a Focal One device sold and installed at Institut Gustave Roussy, Villejuif, in Paris. This is the leading center for the treatment of prostate cancer in France. And one of the most respected centers in the world. They were among the first urology teams to master Laparoscopic and Robotic Radical Prostatectomy. They acquired one of the first Focal One devices based on its unique innovative features and this, its unique capabilities to address the need for focal approach of prostate cancer treatment. They also believe a center of expertise in prostate cancer must have HIFU as part of is armament variant so that each patient can receive the best possible treatment depending on the stage and the type of disease. The second HIFU device was another Ablatherm HIFU machine sold in Egypt which gave us entry to a new country providing them with the novel and non invasive solution to treat their population with localized prostate cancer. The trend continues as we are quite well positioned in Q3 with the backlog of two Focal One devices sold in Switzerland and in Germany, both to luminary centers at the forefront of robotic surgery. Thus with the growing need in a breaking focal approach of prostate cancer in modern environment. These numbers and the increasing use of our complete and unique range of HIFU devices are as mentioned earlier, solid proof of the validation and growing recognition of the HIFU therapeutic option to treat localized prostate cancer from low-risk to high-risk patients. It is becoming clear to the urology community that urologists need to offer several treatment options depending on the patient and his stage of disease. As each case is unique in medicine and even more so when we speak about complex and competitive disease such as prostate cancer. We believe HIFU needs to be part of the patient choice. These results and the continues adoption of our HIFU technology and devices also show the strong base that EDAP has built across the year, thanks to its certified years of experience and expertise in urology as well as its international network of subsidiaries, distributors and agents. The European urology community stood as the leading edge of the growing adoption of focal therapy paradigm and EDAP is very well positioned in this favorable environment.

Regarding our lithotripsy business, we continue to have growth worldwide with 7% of growth for the first half of the year and 18% of growth in Q2. In second quarter, we sold 12 devices in three months. The third quarter looks promising as we already add in backlog 10 devices order and a strong pipeline of projects as we enter the second half of the fiscal year.

To conclude, I would like to highlight some key points to keep in mind. First, EDAP's business is not depended on the sole project of approving HIFU in the U.S., but has a solid revenue base generated through international growth in both HIFU and lithotripsy sales. Second, the FDA approval process for Ablatherm HIFU is not complete as the agency has not made its final decision and it is continuing from going an active review of EDAP's submitted PMA. Three, advisory committee negative vote is neither binding nor it is a decision, this is a recommendation. Four, we are happy and pleased by our strong growth in revenues for the first half of the year and are continuing our sales and marketing actions globally as we enter the second half of 2014. And five, our strong business position is also supported by a significant financial position with cash of $17.5 million at mid year.

I will now turn the line over to Eric, who will discuss great results in greater detail. Eric?

Eric Soyer

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 or EUR 0.23 per diluted share, as compared to a net loss for the second quarter of 2013 of EUR 195,000 or $255,000 or EUR 0.01 per diluted share. Net loss in the second quarter 2014 included non-cash

Interest expense of EUR 3.8 million to adjust the accounting fair value of the outstanding warrants.

As you are now well aware the U.S. GAAP accounting rule would need to address the outstanding once booked value to market fair at the end of each quarter based on the number of market criteria, the most sensitive of those being EDAP fair price. The significant increase in the fair price towards the end of the second quarter 2014 as compared with the end of the first quarter 2014 triggered an increase in the warrant fair value and consequently an interest expense of the same amount in the second quarter 2014 to account for that variation.

For the reader of more consolidated accounts who is not US GAAP expert, this is certainly technical jargon. And makes the understanding of our net results quite confusing. So please keep in mind, first, that the interest expense or income depending mostly on the upward or done with variation in the fair price from one part to the other is a non cash accounting adjustments. And second, that our operating result is most straight forward reflection of EDAP's quarterly economic performance.

Turning now to the first six months of 2014.

Total revenue was EUR 13.4 million or $18 million, up 28% compared to EUR 10.4 million or $13.7 million for the first half of 2013. As Marc already mentioned the growth in the six months period was stemming mostly from a HIFU business with a 104% increase in HIFU revenue year-over-year.

Gross profit for the first six months of 2014 was EUR 5.4 million or $7.2 million and gross profit margin was 40.1%, compared to 36.7 % in the year ago period.

Operating loss for the first six months of 2014 was EUR 1 million or $1.4 million which is EUR 1.6 million reduction from EUR 2.6 million or $3.5 million for the same period last year.

Net loss for the first six months of 2014 was EUR 4.4 million or $5.9 million, or EUR 0.20 per diluted share, as compared to the first six months of 2013 net loss of EUR 4.1 million or $5.3 million. Net loss in the first half of 2014 included a non-cash interest expense of EUR 3.6 million to adjust outstanding warrants to fair value.

And of course my comments about on such adjustments for the three months periods oblige just the same for the six months period. This adjustment is non cash and the operating loss which is again EUR 1 million for the six months period is a more relevant assessment of EDAP's economic performance in the period.

Finally, at June 30, 2014, cash and cash equivalents, including short-term treasury investments, were EUR 12.8 million or $17.5 million. This is a solid position as a company's net utilization of cash for its operation was EUR 0.9 million in the last 12 months.

With that, I'll turn the call over to the operator, who will open the line for questions. Operator?

Question-and-Answer Session

Operator

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

Suraj Kalia - Northland Securities

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?

Eric Soyer

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

Suraj Kalia - Northland Securities

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?

Marc Oczachowski

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.

Suraj Kalia - Northland Securities

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?

Marc Oczachowski

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.

Suraj Kalia - Northland Securities

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.

Marc Oczachowski

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.

Operator

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

George Zavoico - MLV and Co

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?

Marc Oczachowski

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.

George Zavoico - MLV and Co

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

Marc Oczachowski

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

George Zavoico - MLV and Co

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?

Marc Oczachowski

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.

George Zavoico - MLV and Co

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?

Marc Oczachowski

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.

Operator

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

John Harold - Harold and Associates

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?

Marc Oczachowski

Sorry, I didn't get your point.

John Harold - Harold and Associates

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 --

Marc Oczachowski

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.

John Harold - Harold and Associates

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?

Marc Oczachowski

I will leave it to Eric.

Eric Soyer

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.

John Harold - Harold and Associates

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

Marc Oczachowski

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.

Operator

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

Mark Windering- MGW and Associates

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?

Marc Oczachowski

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.

Mark Windering- MGW and Associates

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?

Marc Oczachowski

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

Operator

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

Peter Cardillo - Rockwell Global capital

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?

Marc Oczachowski

Yes.

Peter Cardillo - Rockwell Global capital

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.

Marc Oczachowski

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.

Operator

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

Terry Calrton

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.

Marc Oczachowski

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.

Terry Calrton

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

Marc Oczachowski

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.

Terry Calrton

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?

Marc Oczachowski

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.

Terry Calrton

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.

Marc Oczachowski

Definitely

Terry Calrton

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?

Marc Oczachowski

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.

Terry Calrton

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

Marc Oczachowski

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

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

Ranjit Wali - RK Small Caps

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?

Marc Oczachowski

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.

Ranjit Wali - RK Small Caps

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--

Operator

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

Stanley Besent

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.

Marc Oczachowski

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.

Stanley Besent

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

Marc Oczachowski

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

Stanley Besent

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

Marc Oczachowski

I understand, thank you for that.

Operator

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

RK Ramakanth - H C Wainwright

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?

Marc Oczachowski

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

RK Ramakanth - H C Wainwright

Yes.

Marc Oczachowski

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?

RK Ramakanth - H C Wainwright

Yes, now I can.

Marc Oczachowski

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.

RK Ramakanth - H C Wainwright

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?

Marc Oczachowski

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.

RK Ramakanth - H C Wainwright

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?

Marc Oczachowski

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

RK Ramakanth - H C Wainwright

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

Marc Oczachowski

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.

Operator

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

Philippe Chauveau

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.

Operator

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

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Source: EDAP TMS' (EDAP) CEO Marc Oczachowski on Q2 2014 Results - Earnings Call Transcript
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