Earnings Labs

Edap Tms S.a. (EDAP)

Q2 2013 Earnings Call· Wed, Aug 28, 2013

$3.28

+1.86%

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Transcript

Operator

Operator

Good day. And welcome to the EDAP Second Quarter 2013 Earnings Conference Call. All participants will be in listen-only mode. (Operator Instructions) After today’s presentation, there will be an opportunity to ask questions. (Operator Instructions) Please note this event is being recorded. I would now like to turn the conference over to David Burke with The Ruth Group for the reading of the Safe Harbor. Please go ahead, sir.

David Burke

Management

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. This includes 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 would like to turn the call over to Mr. Philippe Chauveau. Philippe?

Philippe Chauveau

Management

Good morning, everyone. And thank you for joining us on our second quarter 2013 investor conference call. Q2 2013 was a flat quarter, as our business always shows uneven quarters but our pipeline into Q3 and full year 2013 is on track. As a consequence of paying back our $8 million outstanding loan, our balance sheet now has a zero long-term debt and June 2014 is no longer a significant date. Our U.S. based team continues to build our American operational momentum. The company’s net cash position in Q2 remains stable. With that, I’d like to turn over this call to Marc. Marc?

Marc Oczachowski

Management

Thank you, Philippe. And thank you everyone who has joined us for the second quarter 2013 earnings call. I will first review recent developments across our business segments and then I will turn the call over to Eric to discuss the financial results for the quarter. Following Eric comments we will be happy to answer any questions you may have. As outlined in today’s release, we reached a number of important milestones during the second quarter as we continue to further develop our long-term growth strategy. Importantly, we took steps to enhance the strength of our balance sheet with the successful completion of the registered direct placement in May. We effectively deployed a major portion of this capital in mid-June with the full redemption of $8 million in long-term debt that was outstanding. With these actions we have significantly enhanced our capital structure by eliminating the 9% annual interest paid quarterly, representing an immediate savings of approximately $720,000, and have no remaining long-term debt obligation. This positioned the company well going forward enabling us to focus solely on our development project, including the PMA application for HIFU in the U.S. Additionally, during the first half of the year and more specifically this last quarter the accomplishments within our HIFU division were significant. First, we launched and received CE mark for new and complementary HIFU device called Focal One. We received the only HIFU device dedicated to the Focal approach of prostate cancer treatment. It combines the revolutionary HIFU dynamic focusing technology and the MRI dynamic [fusion] with ultrasound localization, as well as contrast imaging enhancement for images monitoring of the treated areas in the prostate during treatment session. Focal One was presented during a world-wide premier at the European Urology Annual Meeting in Milan, Italy, and was received very positively…

Eric Soyer

Management

Thank you, Marc and good morning everyone. I will now take a few minutes to review our financial results for the second quarter and on a six months basis. Total revenue for the second quarter 2013 was €4.5 million or $5.9 million, compared to €6.1 million or $7.8 million for the second quarter 2012. Total revenue for the HIFU division was €967,000 or $1.3 million for the second quarter 2013, compared to €1.1 million or $1.4 million for the same period last year. Results for the second quarter 2013 included the sales of RPP procedures and sales of spare parts and services. Total revenue for the lithotripsy division was €3.5 million or $4.6 million for the second quarter 2013, compared to €5 million or $6.4 million, during the year ago period. During the second quarter 2013, the company recorded sales of eight lithotripsy machines, comprised of five Sonolith i-move devices and three Sonolith Praktis devices, compared to a total of 14 devices sold in the second quarter 2012. Gross profit for the second quarter 2013 was €1.6 million or $2.1 million, compared to €2.4 million or $3.1 million for the year ago period. Gross profit margin was 36.1% in the second quarter 2013, compared to 39.1% in the year ago period. The change in the gross profit margin was mostly attributed to the negative impact of the Japanese Yen exchange rate variations against the Euro. Operating expenses were €3.1 million or $4 million for the second quarter 2013, compared to €3.3 million or $4.2 million for the same period last year. Operating loss was €1.5 million or $1.9 million for the second quarter this year, compared to an operating loss of €937,000 or $1.2 million in the second quarter of 2012. Net loss for the second quarter 2013 was reduced…

Operator

Operator

(Operator Instructions) Our first question is from [Terry Tricartin], a private investor. Please go ahead.

Unidentified Analyst

Analyst

Yeah. Good morning. I’ve got a couple of comments and then I have a few questions. One is I have a perception issue with the company that has developed from the comments, the very brief comments that were made after the June 100-day review meeting with the FDA. And at that time, the very limited comment that was made by Marc regarding the meeting led a lot of the shareholder owners of the company to develop somewhat of a negative perception of things because it seems like the communication was just not there. And I’d like to ask that going forward that you give a more complete description such as the description that you just gave a few minutes ago of these interactions with the FDA. Many of the shareholders, including myself, don’t really have a clear understanding of this timeline interruption or issue that has occurred here. Now one of my questions is why is -- you mentioned that this is the first time the FDA is going to conduct a panel review for prior to approval of the HIFU device. I’d like to know why that is the case. And then secondly, I’d like you to give us an estimated timeline to the best of your knowledge, what’s going to occur going forward and when this is going to happen. People – shareholders, owners of the company need to have this information to get a good feeling for what this going to transpire and when?

Marc Oczachowski

Management

All right. Well, Terry -- why I mean -- first question why is this the first time that the FDA review PMA for prostate cancer because all of the other modalities are so-called grandfathers technology. So they were there before 1976 when the FDA was to review such technologies. So they were there before. So they continued to go for PMA approval. And since then nobody need it. So that’s the first time that they are doing it. But the second question on the timeline is a great question. And I ask -- personally ask that question many times to the FDA team, including the Director of the [Dr. Goods] division that is in-charge of our devices and technologies. The answer I am getting and is very simple is that there are guidances but the agency has no obligation for that. So basically we have and they have no idea and there is no timeframe and no obligation again with any timeframe for the FDA. So it’s extremely complicated to give a timeframe and timeline estimation on any PMA, not only ours but any other PMA. So we can probably estimate but again these are extremely complex processes and you never know along the road the FDA might need to further review, ask more questions, come back on questions, ask for panel meetings, there are so many different things that are out of control and again, the FDA receive the guidances for timing on review, but they have no clear obligation on following that and they will do what they feel is the best for them to get a good review and quality again review of the fact. So it’s only difficult to give timeline. And again, always when we meet with the FDA, these are my questions and they…

Unidentified Analyst

Analyst

Yes. Well, just getting back to the comments made again in that brief press release. As you may have noticed, the limited comments led to a significant reduction in share value. At that time the stock was trading around 350 plus a share and look what it is now. So there is, as a result of the rather I don’t want to sound negative if I say poorly worded or limited statement, the value of the company dropped by $20 million? Now I do appreciate that debt reduction but you have to look at the overall market capital of the company and that’s based upon the share value as much as anything else. So that’s something that I think needs to be kept in mind going forward. So I do appreciate your feedback on that and hopefully you guys can make, again just be -- I realize you can’t share confidential information, but you can at least tell us in as much as possible. So I do appreciate that. Thank you.

Marc Oczachowski

Management

Yeah. We’ll do. Thanks.

Operator

Operator

(Operator Instructions) Having no questions, this does conclude our question-and-answer session. I would like to turn the conference back over to Mr. Philippe Chauveau for any closing remarks.

Philippe Chauveau

Management

There have been no further questions I will now close this conference call and thank you all for participating on today’s conference call. Thank you and talk to you soon. Bye-bye.

Operator

Operator

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