Edap TMS (NASDAQ:EDAP)
Q1 2013 Earnings Conference Call
May 16, 2013 08:30 ET
Stephanie Carrington – Investor Relations
Philippe Chauveau - Chairman
Marc Oczachowski – Chief Executive Officer
Eric Soyer – Chief Financial Officer
Suraj Kalia - Northland Securities
Good day and welcome to the Edap First Quarter 2013 Earnings Conference Call. (Operator Instructions). Please note this event is being recorded. I would now like to turn the conference over to Ms. Stephanie Carrington, Investor Relations for the Ruth Group. Please go ahead.
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 would like to remind everyone that management’s remarks today may contain forward-looking statements. These statements are regarding the company’s growth and expansion plans were included. Such statements are based on management’s current expectations and are subject to number of uncertainties and risks that could cause actual results to differ from those described in any of 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 over the call to Mr. Philippe Chauveau. Philippe?
Good morning everyone and thank for joining us on our first quarter 2013 investment conference call. Q1, 2013 was a productive quarter, EDAP revenues continued as in Q4, 2012 to show high growth specifically 23%, for some strategic reasons at the same time in Q1, EDAP continued to spend significant amounts in the Ablatherm HIFU FDA process which is on schedule.
EDAP continued to make investment in sales and marketing in the U.S. market which is showing good progress. EDAP’s backlog continued strong and cash control is well managed. Now I will turn. Now I’ll turn over the call to Marc.
Thank you Philippe and thank you to everyone who has joined us for our first 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. As we previously announced we saw excellent growth in the first quarter of 2013 with revenues at 22% year-over-year. We’re continuing to see strong demand for our technologically advanced lithotripsy product range in key global markets as we sold 10 devices in the first quarter. Our sales teams are continuing to calculate customer leads around the world and are devised (inaudible) from price of 70 (inaudible) at the mid-point of the second quarter.
The increasingly aggressive marketing strategy that we discussed on the last call is serving the company well and we anticipate continued traction in our sales across geographic markets. The first half of the year was extremely important in terms of international Urology events with both Europe and Urology Association Annual Meeting that was held in Milan, Italy at the end of March and the American Urological Association Annual Meeting that took place in San Diego California for May 3rd through May 8th.
These events are key as they represent unique opportunities to meet thousands of urologists from all over the world and show them our new developments. And this is where we will gather leads and projects to work on and build our business for the months to come. Both conferences were extremely successful for EDAP. We gathered an increasing level of interest and recognition from the urology community for both our HIFU and lithotripsy technologies.
In Milan during the EAU we had the opportunity to release as the world premiere on new additional HIFU device called Focal One. This new and ultimate device would complement both replace our existing Ablatherm HIFU device which is currently the most utilized HIFU device in the world. Focal One brings together exclusive and innovative features such as the electric fusion of MR images and ultra-sound images. Dynamic focusing technology which increases the resolution and accuracy of the HIFU treatment and ultrasound complex enhancements to confirm treatment effect immediately.
Not only is the Focal One the only device to have all three of these features, no other HIFU device has any of these features. These features make Focal One truly unique as it is the only device dedicated to the Focal treatment of localized prostate cancer. We were extremely pleased with the feedback and interest received during three days of demonstrating this innovative device as for EAU boast. However this was not surprising as Focal One was developed and designed based on guidance and advice received from the world leading surgeon urologist inclusive of some of the key and pioneer player in urologic surgery.
During the development phase of Focal One these leading surgeons clearly expressed the need for fresh technology with features to address the growing need for focal approach to treat prostate cancer and to overcome the current limitations of existing technologies and techniques for the modern prostate cancer patient population.
Focal One combined with others in HIFU give that a unique and extended HIFU device offerings that addresses the need of both urologist and patients. Our extended device portfolio provides a wide range of treatment options from compliment to surgery to an effective alternative treatment from the focal dedicated approach to a proven radical treatment as well as addressing the different patient populations ranging from primary care patients to patients that are in need of the salvage treatment.
These continues to validate EDAP to priority in the marketplace in terms of innovation capacity by bringing truly novel devices and technologies based on the same mechanism of actions as opposed to the competition with bringing limited cosmetic improvement to existing devices.
Technological innovation and academic clinical research are fundamentals components of EDAP. We continue to implement refinance across both our product managers (ph). This approach has produced solid results and growth as evidenced by our 23% revenue growth for the first quarter.
In San Diego during the AUA we had tremendous traffic on our booth and gave numerous demonstrations of the Sonolith i-move throughout the day to interested urology professionals. It is clear that U.S. Urologist are becoming more familiar with our brand and our devices as we continue to execute on our U.S. market penetration plan. We were very pleased by positive reception we received at this important urology event which draws attendees from not only the U.S. these but also from around the world. At the AUA we garnered increasing momentum among the U.S. Urologist for HIFU.
Many are following the progress and significant milestones achieved recently in our FDA process and feel that the technology should be read for use in the country in the coming quarters. Using Professor (inaudible) words following the session with several of these American peers and he said we feel that the U.S. Urologists are putting the running shoes on and making sure that we will be ready for raise when the technology is approved by the FDA.
This is exactly we’re really concerned the Urologist wanting to be ready for when it is approved and clearly understood we’re at the final stages of the process. Turning to the EDAP past and the key and critical milestones achieved since the beginning of the year. I would like to highlight that as anticipated we submitted a complete PMA application to the agency at the end of January.
It was reviewed in a timely manner by FDA team in accordance with their new guidance and timely recommendations. We received at the end of March their approval for filing so they could start a substantive review of the application. Let me comment on that specific step. Our PMA application was approved for filing by the FDA. These means we have been qualified by the agency for the substantive review and this is based on the first and only strategic review of our company’s PMA application.
It is also important to know that EDAP is not the only HIFU company or prostate cancer treatment device company to achieve these milestones for the treatment of primary care patients with prostate cancer. Again this positions us as the most innovative company in the field. Finally this was done within the new timeframe and guidance that the agency adopted at the beginning of this year as the filing was cleared in a bit more than 45 (ph) case recommended timeframe.
With this important milestones achieved we’re continuing to work collaborative with the FDA based on smooth communications with the aim of answering questions and providing supporting documents through the agency that will allow the FDA to carry on their substantive reviewing in the best condition and timing. We received a confirm date for the 100 day meeting which is scheduled for the 3rd June at the FDA headquarter. This meeting will provide a forum for us to discuss with the FDA and potentially clarify some of the questions that might be raised by the agency on our PMA application by then, we summarize on this important topic. Things are moving forward very well and smooth for FDA HIFU application process and we’re very excited and enthusiastic as we’re in the final stage of this long process that started more than six years ago.
Finally we are also working on the regulatory program for Focal One on new Focal (inaudible). We’re in the process of having a (inaudible) and anticipate clearance very soon. Subsequent we will navigate the approval processes in other countries allowing us to refer most of countries or confident friends of HIFU devices. As far as the U.S. is concerned our regulatory priority and exclusive project on HIFU remains at a term. Once this is done and cleared we will have several options to present Focal One and this will indeed be discussed with the FDA when it will be the right time to do so. Before turning the call over to Eric for a detailed financial review of the first quarter and as a summary I would like to highlight again the great part of 2013 with 23% growth in our revenues, we will continue supporting this growth initiatives, we will continue to invest in innovation and we will maintain a focus and investment in penetrating the U.S. market with both our technologies.
Finally and as reported recently we’re very proud and happy about the two (inaudible) than 10 year outcomes duplications of Ablatherm HIFU. This is a great achievement and clinical valuation of the ability of HIFU to treat prostate cancer with low mobility and cancer control outcomes that are effective and remain stable over the long term. With that I will 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 first quarter 2013 financial results. Total revenue for the first quarter 2013 was 5.9 million euro or $7.8 million, a 23% year-over-year increase compared to 4.8 million euro or $6.8 million for the first quarter 2012. Total revenue for the HIFU division was 1.4 million euro or $1.8 million for the first quarter 2013 compared to 1.3 million euro or $1.9 million for the same period last year.
Results for the first quarter 2013 included the sale of one Ablatherm HIFU device. In the first quarter 2013, total revenue for the lithotripsy division was 4.5 million euro or $6 million compared to 3.5 million euro or $4.9 million during the year ago period. During the fourth quarter 2013 the company recorded sales of 10 lithotripsy machine comprised of eight Sonolith i-move devices and two Sonolith I-Sys devices compared to a total five devices sold in the first quarter last year.
Gross profit for the first quarter 2013 was 2.2 million euro or $2.9 million compared to 1.9 million euro or $2.7 million for the year ago periods. Gross profit margin was 37.1% in the first quarter 2013 compared to 39.3% in the year ago period. The change in the gross profit margin was mostly due to the negative impacts of the Japanese yen (inaudible) rate to the euro and without that impact gross profit margin was stable at 39.1%.
Operating expenses were 3.4 million euro or $4.5 million for the first quarter 2013 compared to 2.9 million euro or $4.1 million for the same period last year. The sizeable increase in operating expenses was mostly attributable to increased regulatory expenses associated with the PMA filing for Ablatherm HIFU as well as sales and marketing investments in the U.S.
As a result of such investments operating loss was 1.2 million euro or $1.6 million for the first quarter 2013 compared to an operating loss of 1 million euro or $1.4 million in the first quarter of 2012.
Net loss for the first quarter 2013 was 3.9 million euro or $5.1 million or $0.21 of euro per share as compared to net loss for the first quarter 2012 of 2.9 million euro or $4.1 million or $0.22 of euro per share. At this point I need to emphasis that net loss for the first quarter 2013 included a non-cash interest expense of 2.3 million euro related to fair value adjustments in the accounting of the company’s outstanding debt and warrants. Without being too technical, applicable accounting rules would require that our debt and warrants be reevaluated every quarter but a number with a number of market criteria including variations in our stock price. With changes in market value we were effected as an interest income overall.
Although that might sound counter-intuitive for no specialist, the increase in EDAP stock price during the first quarter 2013 results here in accounting interest expense of 2.3 million euro in our P&L. This again a non-cash accounting adjustments, once a nominal amount of our non-convertible financial debt remains unchanged since introduction to $8 million in the second quarter of 2012.
Finally at March 31, 2013 cash and cash equivalent including short term treasure investments were $7.3 million or $9.3 million. The cash utilization in the first quarter resulted essentially from the company’s first in the U.S. to support those FDA regulatory programs and marketing and sales investments. And that was mitigated by strong working capital management.
With that I will turn the call over to the operator who will open the line for questions. Operator?
Thank you sir. (Operator Instructions). The first question will come from Suraj Kalia of Northland Securities. Please go ahead.
Suraj Kalia - Northland Securities
So Marc on forgive me I jumped on about five minutes late on the call, the FDA timeline, I know you had set the floor the 100 days meeting is coming up in June. I guess could you give us any color on panel timing?
We have received no information from the FDA regarding the panel as again the next set will be the Investor meeting and we have no other information from the FDA so basically the 100 day meeting will be held in June 3rd at the FDA headquarters and then after that we may have more I would say the ability and information from the agency.
Suraj Kalia - Northland Securities
But you’re planning for a panel and if other…
This is something that the FDA will plan on us but usually the FDA they will probably ask the panel to meet.
Suraj Kalia - Northland Securities
Fair enough. Marc one another question for you and then I will move on to Eric. And maybe this is an unfair question so forgive me, we all know the genomic health prostate cancer test that was recently it was talked about quite a bit and if I remember reading it correctly they were talking about stratifying the aggressiveness of the prostate cancer from low risk and high risk, I guess the question I have could that be complimentary to something like HIFU and by that I mean you all are targeting low risk localized prostate cancer and a test like that can accurately predict low risk prostate cancer. Do you all see synergies in its potential application if HIFU could eventually fit in?
As you just mentioned Suraj it's a potential application and so far there is still a lot of work to be done on the gene application and treatment. So it's very early say if HIFU that is much more than in the treatment of prostate cancer would be a compliment or would be some synergies between that. The fact is HIFU and that’s one of the beauty of the (inaudible) of HIFU is that it can really be used on different patient population again ranging from very focal and very accurate treatments on very low risk patients to radical treatments and until we have seen publications with extremely encouraging results on HIFU for P3, P4 patients. So again there are lot of applications on HIFU that has been again proven and showed through publications in major journals.
We don’t have that much information yet on the gene application.
Suraj Kalia - Northland Securities
Fair enough Eric, two questions for you if I could, first in terms of FX headwinds, how should we look up at obviously the Yen is getting weaker and you’ll have a lot of foreign currency exposure to the extent that you can walk us through for the remaining three quarters how should we think about FX headwinds and gross margin impact.
Well of course it's something which is quite difficult to predict. As you know we’re doing significant portion of our sales in lithotripsy in Asia and mostly in Japan particularly in Japan, that’s why I was mentioning the FX impact on the Japanese Yen against the euro because this is the one we’re most exposed to but in terms of prediction I believe it's quite difficult to give an outlook on this one.
Suraj Kalia - Northland Securities
Okay and finally Eric forgive me if you mentioned this the contribution in the U.S. lithotripsy?
In the 10 lithotripters that was sold in Q1, one was sold in the U.S. and in the ’10 backlog in mid-point of Q2; two are coming from the U.S.
The next question will come from Rick Deck, a private investor. Please go ahead with your question.
Rick Deck – Private Investor
Just want to see what you can share about HIFU and some of the other cancers that this is being investigated for, how are those trials progressing?
As you may know Rich, we are working on the development phases on some additional applications beyond prostate cancer to use our HIFU technology and expertise, the most advanced is use the HIFU technology for the treatment of liver metastasis as you know liver metastasis are unfortunately quite usual outcome of the colorectal cancer and we have developed a technology that is addressing specifically methods to this in the liver as a complement to surgery. This is still at clinical stage.
Rick Deck – Private Investor
This is progressing well but we cannot comment further until the clinical stage is over.
Rick Deck – Private Investor
Do you know the timing of when the clinical stage would be over?
No I cannot say for now.
(Operator Instructions). The next question will come from (inaudible). Please go ahead.
I have two questions. I have been an investor in the company for quite some time now and anxious to see EDAP exploit the profit potential for marketing the product. This could be through an outright sale or partnership with a large medical device company or by setting up your own HIFU clinics for example. Can you outline revenue model or models that you believe will maximize the return on this decade long investment?
I think several models are available as different countries and markets in the world are different to kind of in their approach, like U.S. very different for example from Europe or rest of the world and I think that the strategy that we have adapted was to again increase our market penetration and increase as well our segment penetration and that’s why we have developed our quite wide range of lithotripters, but also we’re doing that in HIFU and one of the key again in our growth and capability to achieve profitability will be the penetration of the U.S. market that we started very actively a year or a year and half ago and that again will continue and we have extremely strong expectation on the lithotripsy and we have a very strong leverage once HIFU will be approved in the U.S.
And is it your plan to pursue a fee per use model or royalty model upon approval as opposed to outright sale of the devices? Because I believe I think the perception and perhaps the reality is same that sale of the devices is really not led to an extraordinary growth in revenue whereas setting up your own clinics or coming up with a successful fee per use model might be the best method. If you’re going to take this on yourself other than selling the company to large medical device competitors for example. What are your thoughts on that?
Well that’s exactly what we’re looking at now and we are again learning a lot on lithotripsy experience as we are now in constant contact every day with the urology market and the urology environment including urology study providers and other stakeholders in the market. So we have developed and again the device is adaptable to a paper use type of business model or as well as the sale of equipment. So we may work on these several directions and again we’re discussing with most of the pl[Author ID1: at Fri May 17 18:56:00 2013
]ayers and stakeholders here in the U.S. to make sure that we can go to the best model that we have optimized our revenue and margin profit as well.
Secondly leading up to and after approval it will be of great value to use effective public relations to improve investor awareness of the HIFU technique that EDAP is about to introduce to the country. What efforts are being made to get news of this into mainstream business publications or through live television appearances on business networks such as CNBC?
Yes this is exactly what we are again in the last stage of the FDA process we can indeed take the time of working on a marketing and communication program and that’s exactly what we’re doing and that’s part of it.
Yes. That’s great because I think generally speaking there is a presumption that the company would may need to raise capital to develop marketing sales for the product post-approval and that could be best be done through elevating the valuation of the company and as an investor I believe there is a tremendous opportunity to take advantage of by getting news of the product into the mainstream, out of the medical reach and into the mainstream investor community where people can get excited and help elevate the value of the company then secondary could be done at a higher valuation if necessary. So I think that could be a good motivator for you guys to invest little money in positive public relations.
Absolutely we’re relying on that.
(Operator Instructions). Showing no additional questions in the queue, that will conclude the question and answer session. I would like to turn the conference back over to Philippe Chauveau for his closing remarks.
There have been no more questions or comments I would like to close the conference call and I would like to thank you everyone for participating on today’s conference call. Thank you and talk to you soon. Bye.
Ladies and gentlemen that concludes today’s conference call. We thank you for attending. You may now disconnect your lines.
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