David Burke - The Ruth Group, IR
Philippe Chauveau - Chairman
Marc Oczachowski - Chief Executive Officer
Eric Soyer - Chief Financial Officer
EDAP TMS SA (EDAP) Q2 2013 Results Earnings Call August 28, 2013 8:30 AM ET
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.
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?
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?
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 by the urology community. This is so unique and clear answer in the new need in the management of prostate cancer and the real innovation in the modern era of prostate cancer treatment.
Second, three major clinical paper from three different sites in two different countries were accepted for publication in three of the most respected journals, including the American Journal of Urology. These papers cover more than 2,000 patients with 10-year follow up after Ablatherm-HIFU.
This is noteworthy recognition of our technology as a standard of care treatment for prostate cancer. It is also quite unique as most of the other treatment modalities do not have such papers covering these many patients with such long-term follow up.
We believe this is key as it shows excellent results in the efficacy of Ablatherm-HIFU in the treatment of prostate cancer with very high level results in terms of free survival and metastatic-free rates.
This will certainly contribute to our ability to move forward into different regulatory program and pass around the world and in the U.S. [Mostly], these publications can certainly be provided on request.
Finally, in early June we had our 100-day meeting with the FDA regarding our Ablatherm-HIFU MPA application. This is the standard meeting with the FDA in which we discuss the progress and points of the application following the first set of questions and remarks, while the attempt to review our accepted file submission. This is an opportunity for the company to ask questions in response to the agencies remarks later.
We can’t disclose too much information on our ongoing discussion with the agency as this is highly confidential, but we can say that it was a very constructive meeting. Again, this is a first time the FDA has run a PMA for approving a technology to treat prostate cancer and as such, it makes it a type of [out of the buck] project. Therefore, we are working with the FDA as a team in accordance with the rules and regulations as we move forward in the different stages of the approval process.
We understand that our final application will also be submitted to a panel [of directors] for their review. We also understand that there is a certain delay in getting a panel success to meet and we will need to go through the questions as they review our answers and then come then to the panel. All these will take a few months to complete.
However, the company and our team of expert consultant remained focus on this project and are working hard in order to move forward as quickly as possible, and are providing the FDA review team with the highest quality of information necessary.
In terms of our operations, we maintain our focus on expanding the company’s presence world-wide to penetrate more market and offer our ranges of technologies to a broader OEMs.
Our second quarter sales came in at €4.5 million, while sales were impacted by customer-related factors that lead to the postponement of several pending lithotripsy projects that were on track to close in June, we confirmed invoice and delivered this project in July.
And July sales has continued to progress well as we reach the end of August. Despite this delay in converting some of our confirmed orders into sales in Q2 and the negative impact of currency exchange rates mainly due to Japanese Yen, we had a limited decrease in revenues as compared to the year ago results.
As most of you know, the second half of the year is the most critical and crucial part of our fiscal year due to the seasonal effect in our business. And we are working out to grow our pipeline of projects and transform our lead into closed and confirmed deals by the end of the year.
Also, of note during the quarter was the confirmation of the first order for the Focal One unit, which is scheduled for delivery in the course of Q4 of this year, as planned. We continue to see high acceptance of this revolutionary and fully innovative device for focal treatment of prostate cancer and are excited about this prospect.
To conclude, we accomplished several significant and constructive milestones during the second quarter. And we continue to focus on our major projects to further grow our company and its technologies as we move into the second half of the year.
With that, I would like now to turn the call over to Eric. Eric?
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 to €195,000 or $255,000, or €0.01 per diluted share, as compared to net loss for the second quarter 2012 of €3 million or $3.8 million, or €0.16 per diluted share. Net loss for the second quarter 2013 included interest income of €1.9 million as a result of non-cash accounting adjustments related to the full redemption in June this year of the company's $8 million long-term debt and to fair value variations of the company's outstanding warrants.
As a consequence of paying back this loan, the company has no zero long-term financial debt, which is a significant improvement of a financial profile. And its early redemption also as Marc already reminded save the company $720,000 per year in interest expense.
Turning now to the six months period, total revenue for the first half of 2013 was €10.4 million or $13.7 million, down 4.9% compared to €11 million or $14.3 million for the first half of 2012. Total revenues would have experienced moderate growth of 2% except for the €0.8 million negative impact of currency exchange rate variations against the euro.
Gross profit for the first half of 2013 was €3.8 million or $5 million. And gross profit margin was 36.7% and 39.5% on a like-for-like basis after adjusting for the currency exchange variations, compared to 39.2% in the year ago period.
Operating loss for the first half of 2013 was €2.6 million or $3.5 million. And net loss for the first half of 2013 was €4.1 million or $5.3 million, or €0.20 per diluted share, as compared to net loss of €5.9 million or $7.6 million, or €0.32 per diluted share, in the first half of 2012.
Net loss for the first six months of 2013 included a non-cash interest expense of €0.4 million to reflect the full redemption of the company's long-term financial debt and accounting fair value adjustments on its outstanding warrants.
At June 30, 2012 -- 2013, cash and cash equivalents, including short-term treasury investments, were €7.4 million or $9.6 million, which is to say that the company's net cash position remain stable in the second quarter of 2013.
With that, I will turn the call over to the operator who will open the line for questions. Operator?
(Operator Instructions) Our first question is from [Terry Tricartin], a private investor. Please go ahead.
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?
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 understand, and they tell me that they understand that for business purposes we need to have idea on how long it will take, so they can commit on anything and they can promise on anything and there are no obligations on anything.
So that’s a very difficult point and to come back on the communication right after the 100-day meeting, I quite agree with you. But again there are few things that you investors and shareholders may understand as well is that the FDA makes it very clear as well that what we discussed during face-to-face meeting or conference call meetings are part of the side and extremely confidential.
So we can’t release publicly a lot of the discussions and a lot of the points of our discussions with the FDA without kind of going against the rule of breaking the confidentiality agreement that we have with the agency and we receive a lot of pressure from the market because and we understand that you want to know what has happened and what were the conclusion of such meetings. And so we are increasingly confidentiality obligation we have with the FDA and also the willingness of communicating to the market what’s happening and what’s going on. So it’s difficult to communicate on the FDA’s discussions and processes.
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.
Yeah. We’ll do. Thanks.
(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.
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.
The conference is now concluded. Thank you for attending today’s presentation. You may now disconnect.
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