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Edap Tms S.a. (EDAP)

Q3 2012 Earnings Call· Wed, Nov 21, 2012

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Transcript

Operator

Operator

Hello and welcome to the EDAP Third Quarter 2012 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 that this event is being recorded. Now I’d like to turn the conference over to Stephanie Carrington. Ms. Carrington, please go ahead.

Stephanie Carrington

Management

Thank you, Keith. With us today for 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 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 over the call to Mr. Philippe Chauveau. Philippe?

Philippe Chauveau

Management

Good morning, everyone and thank you for joining us on our third quarter investor conference call. This quarter we continue to make headway in the global lithotripsy market, gaining traction in the U.S. as well as abroad with the sale of 12 devices. We were especially pleased to see the increased sales in non-European countries. We believe that was the excellent lithotripsy product we offer, we will continue to see growth in the U.S. as well as steadily increase our share in that market. We were cash positive in the third quarter of 2012 and we also look forward to fulfilling the replenished backlog for the fourth quarter. Marc, over to you.

Marc Oczachowski

Management

Thank you, Philippe, and thanks, everyone for joining our third quarter 2012 earnings call. We will review recent developments across our business segments and then we will turn over the call to Eric to discuss the financial results. Our third quarter 2012 results were in line and we generated positive cash flow during the quarter. The strong revenues from the first nine months of 2012 reflected the robust sales growth of our renewed lithotripsy device platform. In the third quarter of 2012 we sold 12 devices and generated lithotripsy revenues of €4.8 million or US$6 million. As we approach the last week of November, our replenished device backlog is comprised of 19 lithotripsy devices and three Ablatherm-HIFU devices. We are continuing to pursue sales and marketing initiatives around the globe. As we recently announced, we have further strengthened our U.S. sales team with the appointment of Bill Brown as our second U.S. based Senior Sales Manager experienced in lithotripsy. With more than two decades in medical field and over 10 years in lithotripsy device sales, Mr. Brown joins EDAP’s U.S. team to enhance the market penetration of the Company’s Sonolith i-move extracorporeal lithotripsy system and expand U.S. lithotripsy sales initiatives. We continue to grow our revenues in lithotripsy which is a result of our revolutionary range of devices and a strong added value to practitioners and patients. As we stated also few weeks ago, our complete range of lithotripter is now approved in most of the markets worldwide and we can see the impact of this larger market share reflected by further growth in our revenues this year. These advances are very encouraging and we will continue to work aggressively to benefit new markets and to offer our innovative technology to urologists around the world. Now I’d like to turn…

Eric Soyer

Management

Thank you, Marc, and good morning, everyone. I will now take a few minutes to review our financial results for the third quarter and the first nine months ended September 30, 2012. Total revenue for the third quarter 2012 was €5.7 million or US$7.1 million compared to €6.1 million or US$8.6 million for the third quarter of 2011. Total revenue for the lithotripsy division was €4.8 million or US$6 million for the three months ended September 30, 2012, up 1% as compared to €4.7 million or US$6.7 million for the year-ago period. During the third quarter 2012, the Company recorded sales of 12 lithotripsy machines, comprised of six Sonolith i-move devices, three Sonolith i-sys devices, and three Sonolith Praktis devices, compared to a total of 14 devices sold in the third quarter of 2011. Total revenue for the HIFU division was €0.9 million US$1.1 million for the third quarter 2012, compared to €1.4 million or US$1.9 million for the same period last year. Gross profit for the third quarter 2012 was €2.2 million or US$2.8 million, compared to €2.6 million or US$3.6 million for the year-ago period. Gross profit margin was 39.6% in the third quarter 2012, compared to 41.8% in the year-ago period. The change in the gross profit margin was attributed to the evolution in product mix. Operating expenses were €2.6 million US$3.3 million for the third quarter 2012, compared to €2.8 million or US$3.9 million for the same period in 2011. Operating loss was €341,000 or US$429,000 for the third quarter 2012, compared to €195,000 or US$ 275,000 in the third quarter of 2011. I’m turning now to the results for the first nine months of 2012. Total revenue was €16.6 million or US$21.4 million, up 13% as compared to €14.8 million or US$20.9 million in the…

Operator

Operator

Thank you. We will now begin the question-and-answer session. (Operator Instructions) And the first question comes from Jeffery Cohen of Ladenburg Thalmann. Jeffery Cohen - Ladenburg Thalmann & Co.: Hi, thanks for taking my questions and good morning. Could you talk about how many lithotripsy devices are out there in the marketplace currently?

Marc Oczachowski

Management

Yeah, you mean -- hello Jeff, you mean the install base of EDAP? Jeffery Cohen - Ladenburg Thalmann & Co.: Yes.

Marc Oczachowski

Management

It’s about – a little bit more than [500] machines. Jeffery Cohen - Ladenburg Thalmann & Co.: Okay and how many HIFU machines?

Marc Oczachowski

Management

We had approximately in the field about 80 machines. Jeffery Cohen - Ladenburg Thalmann & Co.: Okay, 80 machines and could you talk a little bit about, did you get back to the FDA and talk about your anticipated timeline if they – if the submission goes in the beginning of the year. What that might look like as far as our submission trial timeline, number of our anticipated patient’s outcomes and number of months to some results to be submitted?

Marc Oczachowski

Management

So, actually we – as I said, we expect to submit [outside] the FDA in the early days of January next year. Now, again in terms of publishing the clinical results we’re – we have no idea when we could do that and we won’t take and we won’t make any decision on that without the advice and the recommendation from the agency as we don’t want to interfere at all in their interpretation process of the clinical results of the trial. Now, as the timeline – again it’s in the hand of the FDA and they have received new guidance and timeframe to review file that again they’re the one deciding on that and again what we will do and that’s what we somehow discussed and confirmed to them that we will be available and make everything available to them so that they can review it in the best manner and with the most effective way so that it could be as quick as possible in their review process and we will be supportive and again supporting them with all the information (indiscernible) on that. So we’re in extremely good relation with the FDA and we’re working very closely with the team that we’ve been meeting and known for the past few years. Jeffery Cohen - Ladenburg Thalmann & Co.: Okay, perfect. Thank you very much.

Marc Oczachowski

Management

You’re welcome.

Operator

Operator

Thank you. (Operator Instructions) The next question comes from David Ginter of Oak Ridge Financial.

David Ginter - The Oak Ridge Financial Services Group, Inc.

Analyst

Good morning. Two questions here in regards to your backlog with lithotripsy sales and the Ablatherm. Are any of these sold in the United States?

Marc Oczachowski

Management

Well, for the Ablatherm of course not as – again the Ablatherm is not approved, so we cannot commercialize it in the U.S. On the backlog in confirm purchase order we don’t have any of any machine in the U.S. but we may expect some few as again – our strengthened team in the U.S. is working on a very important and very active pipeline of project. So we don’t have yet in hand, but we expect to have some few by the end of the year.

David Ginter - The Oak Ridge Financial Services Group, Inc.

Analyst

Okay. So, as far as the Ablatherm, none can be sold in the U.S. until you actually have approval?

Marc Oczachowski

Management

Right.

David Ginter - The Oak Ridge Financial Services Group, Inc.

Analyst

Okay. All right. Thank you.

Marc Oczachowski

Management

You’re welcome, David.

Operator

Operator

Thank you. And the next question comes from (indiscernible), private investor.

Unidentified Analyst

Analyst

Yes, hello everyone.

Marc Oczachowski

Management

Hi.

Unidentified Analyst

Analyst

Thank you for taking my questions. Two questions, one is can you please help reconcile the difference between the HIFU as a technology and the decline in HIFU revenues is the first part. And then secondly, you said some questions on the progress of some of the other cancers that HIFU is being tested for?

Marc Oczachowski

Management

Okay. On the first question, this is of course a difficult question to answer, but I think one thing that is – that we feel around the world is that until HIFU is approved in the U.S. its – I mean the FDA is a clear recognition for a technology, so it helps developing further sales of course in the U.S. but also in the rest of the world. And as well as you know, as we explained the treatment of localized prostate cancer is in the middle of a big change as again the patient profile has changed and now more and more I mean radical treatments are seen as all the treatment of prostate cancer so, the trend is to go to a watchful waiting or no treatments or to the focal approach for which HIFU brings a lot of added value and interest for both the patient and the urologist, but it takes always a lot of time to define exactly what is this new focal strategy of treatment and how do they recruit patient, which patient is a good candidate for that and which technology. So it’s taking time, it’s changing, but fortunately for HIFU it looks like all the change in the strategy of treatment as well as in the patient profile moved in the right direction for HIFU to become a real player and (indiscernible) get treatment for prostate cancer. So that will take time, and I think what will help is also the approval of the technology by the FDA that will definitely help the recognition of HIFU around the world.

David Ginter - The Oak Ridge Financial Services Group, Inc.

Analyst

When do you see the …

Marc Oczachowski

Management

On the others and as we announced several time, we continue working and developing clinical trials and R&D research work for several other applications. And again as we went through the Focused Ultrasound meeting in Washington DC we could see a lot of work and a lot of research being done for a lot of different application on HIFU which confirms again the strong interest and the strong plate that HIFU will have in different therapeutic treatments within the next few years.

Unidentified Analyst

Analyst

Okay, great. Thank you.

Marc Oczachowski

Management

You’re welcome.

Operator

Operator

Thank you. (Operator Instructions) Okay. There are no questions at the present time. So, I like to turn the call back over to Philippe Chauveau for any closing remarks.

Philippe Chauveau

Management

Thank you everyone for participating on today’s conference call. As there are no further questions, I’m thus closing our Q3 2012 conference call. Thank you and good bye.

Operator

Operator

Thank you. This concludes today’s teleconference. You may now disconnect your phone lines. Thank you for participating and have a nice day.