Seeking Alpha
We cover over 5K calls/quarter
Profile| Send Message| ()  

Executives

Philippe Chauveau - Chairman

Marc Oczachowski - CEO

Eric Soyer - CFO

Stephanie Carrington - The Ruth Group

Analysts

Jeffery Cohen - Ladenburg Thalmann & Co.

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

EDAP TMS S.A. (EDAP) Q3 2012 Earnings Conference Call November 21, 2012 8:30 AM ET

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

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

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

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 to our Ablatherm-HIFU division. First, as we announced this morning, in early November we had a very productive pre-PMA meeting with the U.S. FDA to discuss our submission for the Ablatherm-HIFU Phase II/III clinical trial for the indication of low risk, localized prostate cancer. This meeting was in line with our continuous good relations with the agency, as we’ve been working closely and communicating often with their team since the beginning of our U.S. clinical trial several years ago.

This FDA meeting was to review the [scripture] of our file and to discuss the next steps of the regulatory process for the other than HIFU trial, including the submission of the complete PMA file to the FDA for their review. It was also the opportunity to revisit the agencies expectations (indiscernible) for the review and evaluation of the file under the best possible Commission. The meeting was also [enrolled] as to gain constructive and positive feedback from the FDA teams, which we intend to follow.

As far as timing and next steps are concerned, we’re conducting in-depth analysis of the data and the [resultant] statistic, that we can provide the agency with the best sets of data. It is imperative that the complete filing is delivered properly and as promptly as possible. We understand this clearly and we will make the necessary actions and thank to have this [file] completed with all details of the data and analysis, so that the package is in accordance with the FDA’s expectations.

Our goal is to set as much time as possible during the review process by submitting a comprehensive initial filing. Following these constructive and positive meeting with the agency and according to the discussions and recommendations we received and are incorporating with project that the submission of our file will be in the first days of 2013.

We also believe that by taking this additional time before submitting the filing, we may save few weeks of back and forth with the agency during the review process. We’re pleased to see that HIFU is continuing to gain recognition as a therapy for localized prostrate cancer. In October urologists with long-term experience using Ablatherm-HIFU participated in panel discussions at the Third International Symposium on Focused Ultrasound.

On two separate panels, they outlined their experience using ultrasound guided Ablatherm-HIFU to treat prostate cancer and highlighted Ablatherm-HIFU's substantial clinical track record, with more than 32,000 prostate cancer treatments successfully performed.

In closing, I’d like to summarize that we’re very pleased with our 2012 revenues as we concluded the third quarter with global revenue growth of 13%. As up to-date we have a strong backlog for the remaining quarter of the year that give us great expectations for the full fiscal year.

Finally, we continue to focus on our top priority projects, which consists of pursuing FDA approval for HIFU. As I discussed earlier, we’re moving forward very well and remain in close communication with the agency to make sure we optimize the timing and chance of success of the project.

With that, I’d now like to turn the call over to Eric, who will review our third quarter 2012 financial in more detail. Eric?

Eric Soyer

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 first nine months of 2011. Gross profit for the first nine months of 2012 was €6.6 million or US$8.4 million, up 8.0% from €6.1 million or US$8.6 million for the first nine months of 2011. Gross profit margin was 39.3% in the first nine months of 2012, compared to 41.0% in the first nine months of 2011

Operating loss for the first nine months of 2012 was €2.3 million or US$2.9 million compared to €2.1 million or US$3 million for the same period of 2011. Net loss for the first nine months of 2012 was €6.4 million or US$8.2 million, or €0.37 per diluted share as compared to net loss of €359,000 or US$510,000 or €0.03 per diluted share in the first nine months of 2011.

Net loss of €6.4 million for the first nine months of 2012 included a non-cash interest expense of €3.5 million to reflect the accounting impact of the January 2012 exchange offering on its convertible debentures and related warrants. This is again mere actuarial fair value accounting with no impact on cash.

At September 30, 2012, cash and cash equivalents, including short-term treasury investments were €8.1 million or US$10.5 million. Net cash of €74,000 was generated during the third quarter 2012. In the first months of 2012, total cash generation was €1.6 million; €1.5 million of these was attributable to the Company’s financing activities mostly the capital raise and the debt reduction executed in the first half of the year. And over the nine months period the Company’s operations did not burn cash as a result of strong cash management improving the Company’s working capital.

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

Question-and-Answer Session

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

Yeah, you mean -- hello Jeff, you mean the install base of EDAP?

Jeffery Cohen - Ladenburg Thalmann & Co.

Yes.

Marc Oczachowski

It’s about – a little bit more than [500] machines.

Jeffery Cohen - Ladenburg Thalmann & Co.

Okay and how many HIFU machines?

Marc Oczachowski

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

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

You’re welcome.

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.

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

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.

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

Marc Oczachowski

Right.

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

Okay. All right. Thank you.

Marc Oczachowski

You’re welcome, David.

Operator

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

Unidentified Analyst

Yes, hello everyone.

Marc Oczachowski

Hi.

Unidentified 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

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.

When do you see the …

Marc Oczachowski

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

Okay, great. Thank you.

Marc Oczachowski

You’re welcome.

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

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

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

Copyright policy: All transcripts on this site are the copyright of Seeking Alpha. However, we view them as an important resource for bloggers and journalists, and are excited to contribute to the democratization of financial information on the Internet. (Until now investors have had to pay thousands of dollars in subscription fees for transcripts.) So our reproduction policy is as follows: You may quote up to 400 words of any transcript on the condition that you attribute the transcript to Seeking Alpha and either link to the original transcript or to www.SeekingAlpha.com. All other use is prohibited.

THE INFORMATION CONTAINED HERE IS A TEXTUAL REPRESENTATION OF THE APPLICABLE COMPANY'S CONFERENCE CALL, CONFERENCE PRESENTATION OR OTHER AUDIO PRESENTATION, AND WHILE EFFORTS ARE MADE TO PROVIDE AN ACCURATE TRANSCRIPTION, THERE MAY BE MATERIAL ERRORS, OMISSIONS, OR INACCURACIES IN THE REPORTING OF THE SUBSTANCE OF THE AUDIO PRESENTATIONS. IN NO WAY DOES SEEKING ALPHA ASSUME ANY RESPONSIBILITY FOR ANY INVESTMENT OR OTHER DECISIONS MADE BASED UPON THE INFORMATION PROVIDED ON THIS WEB SITE OR IN ANY TRANSCRIPT. USERS ARE ADVISED TO REVIEW THE APPLICABLE COMPANY'S AUDIO PRESENTATION ITSELF AND THE APPLICABLE COMPANY'S SEC FILINGS BEFORE MAKING ANY INVESTMENT OR OTHER DECISIONS.

If you have any additional questions about our online transcripts, please contact us at: transcripts@seekingalpha.com. Thank you!

Source: EDAP TMS's CEO Discusses Q3 2012 Results - Earnings Call Transcript
This Transcript
All Transcripts