Edap Tms SA (EDAP) 2009 Q4 法說會逐字稿

Greetings. And welcome to the EDAP fourth quarter and full-year 2009 conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. (Operator Instructions). As a reminder, this conference is being recorded.

It is now my pleasure to introduce your host, R.J. Pellegrino of The Ruth Group. Thank you, Mr. Pellegrino, you may begin.

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. These include 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 the call over to Mr. Philippe Chauveau. Philippe?

Good morning, everyone. I will begin this call by sharing with you some opening remarks. The year 2009 was a strong performance year for EDAP. One, EDAP revenue grew in both divisions; two, EDAP's gross profit margin reached a five-year high; and three, EDAP's cash position finished strong at over $18 million.

We continue to advance towards Company profitability as, excluding FDA trail expenses, we approach the break-even point.

I will now hand over to our CEO, Marc Oczachowski.

Thank you, Philippe, and everyone for joining us on the fourth quarter and full-year 2009 earnings call. We are very encouraged by our third consecutive full year of record revenue in 2009 despite a challenging economic environment.

As outlined in our press release, full-year revenue increased to EUR24.9 million; up 7.9% year-over-year. The increase is attributed to strong operating results from both our HIFU and Lithotripsy division, driven by the growing adoption and expansion of EDAP's innovative technology as we further penetrate existing markets and expand into new geographic territories.

We also continue to advance towards profitability as our activities outside of the US approach break-even.

We will continue to focus our efforts on bringing the Company to profitability through strong operating efficiencies and focused business development initiatives.

After returning our strong full-year 2009 performance, I will address you on our recent accomplishments, including the Japanese [attributable] for Sonolith I-Sys, and then provide an update on our US ENLIGHT clinical trial, evaluating Ablatherm-HIFU as a minimally invasive treatment approach for localized prostate cancer.

For the full-year 2009, Lithotripsy revenue increased 10.1% versus the prior year period.

The Sonolith I-Sys, our new and innovative lithotripsy device, continues to drive sales growth and contributes to a more favorable product mix. Our customers are demonstrating high acceptance of the device's superior dual imaging systems technology and user-friendly features, which have contributed to impressive adoption, positive treatment outcomes, and high standards that benefit both patients and hospitals.

In 2009, we sold 38 lithotripsy machines, including 14 Sonolith I-Sys devices.

Following my previous remarks about the expansion of our technology into new geographic markets, we are very pleased by the US approval of [Sonolith I-Sys lithotripter] in 2009 and its recent approval in Japan.

Japan is the number one lithotripsy market in the world, in both total lithotripsy sales, volume, and [store base].

This approval is a major milestone, and further validates EDAP's position as a major global provider of innovative lithotripsy machines with Sonolith I-Sys now approved in all lithotripsy markets around the world.

With unit integrated and robotized features, Sonolith I-Sys fully meets the Japanese lithotripsy market demands for new high-end technologies. We are confident that high-end device will allow us to successfully address patient and physician needs within major clinical centers and university hospitals.

[Coinciding] with approval in Japan, the [new] Japanese Urology Association, JUA, congress will be held in Morioka from April 27 to 30th in 2010. Sonolith I-Sys will be highlighted in the congress as the latest innovative lithotripsy device.

We look forward to leveraging the Japanese marketing approval to significantly expand our business development efforts in Japan. Our sales and marketing team is already aggressively promoting our device to the medical community, and we look forward to driving uptake and further adoption.

As I mentioned in our third quarter 2009 conference call, the US FDA approval of Sonolith I-Sys confirms our ability to navigate the US regulatory process, and validates the need for a robotized user-friendly technology in one of the largest lithotripsy markets.

Less than two months after the FDA clearance, we've secured our first sales contract with HealthTronics, a major US lithotripsy provider with one of the largest installed base.

During the fourth quarter, we appointed Jeff Howell US-based Vice President of Sales and Marketing. He is responsible for leading US commercialization efforts for (inaudible) Sonolith I-Sys, and his successful background in lithotripsy in the US is a significant addition to the EDAP team. He contributes a successful track record in the field of urology, combined with a deep understanding of the urological US device market.

Jeff is driving our US Sonolith I-Sys commercialization initiatives and positioning EDAP to effectively and rapidly penetrate the US lithotripsy market.

Finally, we are pleased by the evidence that innovation and high-end technology in the medical fields are key parameters to market adoption and growth, as demonstrated by the success of our Sonolith I-Sys.

For three years, EDAP has successfully developed innovative concepts and technologies that position us as a worldwide leader in therapeutic ultrasound. We are actively working to maintain this leadership by continuing to develop next generation technologies and devices that provide minimally invasive treatments for physicians, while improving quality of life and recovery time for their patients.

We also continued expansion of Ablatherm-HIFU by penetrating existing markets and entering new markets as a safe, proven, and non-invasive treatment option for localized prostate cancer.

As expected, much of our third quarter 2009 backlog was successfully converted into revenue during the fourth quarter.

The fourth quarter was the strongest quarter of 2009, with a total of four Ablatherm-HIFU systems sold. In particular, the progress and continued revenue per procedure, or RPP, sales momentum resulted in a 24% growth in RPP treatments during the full-year 2009 compared to the year-ago period.

We also continued to expand our Ablatherm-HIFU installed base. During the fourth quarter 2009, two major hospitals in Europe, la Pitie-Salpetriere Hospital in Paris, France and Azienda Hospital in Pordenone, Italy, placed orders for the device.

We are proud to point out that these two particular Ablatherm-HIFU sales were recorded with hospitals transitioning from RPP model to direct ownership, reflecting successful adoption of HIFU technology and validating our RPP strategy.

As new sides take advantage of our RPP model and treat a growing number of patients using HIFU, they have the opportunity to experience its benefits for both the hospital and its patient and make machine ownership economically practical.

Outside of Europe, Ablatherm continues to penetrate new markets. RPP treatments have increased in the Netherlands, Mexico, and several countries in South America, including Bolivia and Ecuador.

Following Ablatherm-HIFU's recent approval and first sale in Taiwan, additional Ablatherm treatments were successfully performed in the Republic of Taiwan, one of the largest medical device markets in Asia. And additional patients are scheduled to receive HIFU at these centers in the coming weeks.

We continue to work closely in fine-tuning our sales and marketing strategy to support RPP growth as we are constantly exploring new initiatives to drive increased patient awareness and adoption of HIFU technology among the medical community.

There are certainly additional promising markets for Ablatherm-HIFU as we see increasing demands in niche markets where Ablatherm-HIFU can provide unique and exclusive features, such as salvage treatment after radiation. We also see the potential for expansion giving recent excitements around the focal therapy approach for localized prostate cancer treatment.

In addition to the growing adoption of our technology, EDAP has been further supported by growing recognition as an innovative provider of minimally invasive treatment modalities within the urology community.

During the fourth quarter 2009, we participated in the third International Workshop of Focal Therapy and Imaging of Prostate and Kidney Cancer held in Washington DC from February 24 to 27. This was an excellent forum for EDAP to directly address physicians' interest in Ablatherm-HIFU technology and showcase our leadership in cutting-edge focal therapy.

We are confident that focal therapy represents the new trend and future approach to prostate cancer treatment as a targeted less invasive course of therapy.

At the event, Professor Christian Chaussy from Munich, Germany, a (inaudible) supporter for more than 15 years and the most experienced urologist in HIFU worldwide, moderated sessions and presented the growing interest and perspectives in Europe of focal therapy for prostate cancer.

Professor Roland Van Velthoven from Institut Bordet, Belgium, and Dr Sebastien Crouzet from Edouard Herriot Hospital, Lyon, France, also presented promising results on focal Ablatherm-HIFU as the primary treatment for localized cancer and salvage radiotherapy.

In the past 10 years, more than 21,000 Ablatherm-HIFU treatments have been performed worldwide. Expert physicians in Europe, who have had several years' experiences with Ablatherm, are now keen to adopt a more focal approach to the disease that offers patients the ability to fully control their early stage prostate cancer, while minimizing side effects and improving quality of life.

Today, technologies exist to frequently detect early stage low-grade prostate cancer. This is [varying] the growth of minimally invasive approaches, such as focal Ablatherm-HIFU therapy.

We believe these therapies will play an increasing role in (inaudible) targeting tumors and controlling disease, while reducing risks for incontinence and impotence. This point of view is supported by the growing number of Ablatherm-HIFU European sites at opening the focal treatment efforts.

Further, confirming the high level of interest, a clinic study was initiated in September 2009 by AFU, the French Urology Association, in which 10 clinical centers will validate the effectiveness of Ablatherm-HIFU focal therapy and demonstrate the significant patient benefits.

Before I turn over the call to Eric, I would like to address the status of our Ablatherm-HIFU clinical trial in the US. As previously announced, we have had several proactive meetings with our FDA [first] in the past few weeks to discuss alternatives and options to improve our clinical study and to review guidelines for submitting a trial protocol amendment.

We will use the FDA's feedback as a guideline for identifying study design options that would keep the ENLIGHT study within an acceptable cost and deliver clinical results within a reasonable timeframe. Following our current discussions and review, we will have a deeper clarity to provide a [model] for US Ablatherm clinical strategy in the next few weeks.

While we undertake these initiatives to [assert] the [cryoablation] arm, we continue to enroll and treat patients in the HIFU study arm of the trial. We are encouraged by an increasing number of HIFU patients screened and scheduled for treatment. To date, we have treated 112 patients in the HIFU arm, and we are confident that the growing momentum in enrolments will continue.

In summary, we are very pleased to report strong full-year 2009 performance in the face of the challenging economic environment. Both our HIFU and Lithotripsy divisions are performing well in Europe and gaining broad attraction in new markets. We are also proceeding towards profitability as our activities outside of the US approach break-even.

As the leading global expert in High Intensity Focused Ultrasound, EDAP has built a successful track record of developing and marketing devices based on innovative technology. We look forward to expanding our activities and introducing high technology, minimally embedded solutions to sustain EDAP's long-term growth.

I would also like to conclude by highlighting our strong cash position at the end of 2009 and confirm that we are focused on preserving our cash. Our capital will continue to be used in the best interests of our shareholders. We will strategically invest in development projects that will drive the long-term strength of our global operations and continue to position EDAP as a worldwide leader in therapeutic ultrasound.

I will now turn the call over to Eric, who will review our fourth quarter and full-year 2009 financials.

Thank you, Marc. And good morning, everybody. I am pleased to review a strong full-year and fourth quarter 2009 financial results.

Despite a challenging economic environment, we're encouraged to report our third consecutive full-year of record revenue in 2009. Total revenue for the 12 months ended December 31, 2009 increased to EUR24.9 million, or $34.7 million; up 7.9% from EUR23.1 million, or $33.9 million, in the full-year 2008.

Total revenue for the full-year 2009 was driven by continued ramp-up of RPP treatment volumes and a more favorable mix in lithotripsy machine sales. Fourth quarter 2009 total revenue was EUR8.1 million, or $11.9 million; the strongest quarter of the year, reflecting typical seasonality in sales during the last quarter of the year.

During the full-year of 2009, total revenue for the HIFU division was EUR9.6 million, or $13.4 million; an increase of 4.7% compared to EUR9.2 million, or $13.5 million, for the full-year 2008.

We sold seven Ablatherm-HIFU machines, compared to seven devices sold in the prior year. In addition, full-year 2009 HIFU RPP treatments continued to pick up momentum increasing 24% year-over-year.

For the fourth quarter 2009, total revenue for the HIFU division was EUR3.3 million, or $4.8 million, representing the strongest quarter of the year with a total of four Ablatherm-HIFU devices sold.

For the 12 months ended December 31, 2009, we sold 38 Lithotripsy machines, including 14 Sonolith I-Sys devices, for total revenue of EUR15.3 million, or $21.3 million, an increase of 10.1%, from 49 machines, including nine Sonolith I-Sys devices, a total Lithotripsy revenue of EUR13.9 million, or $20.4 million, during the 12 months ended December 31, 2008.

Our new and innovative Sonolith I-Sys device continues to drive sales growth and contributes to a more favorable product mix. During the fourth quarter 2009, total revenue for the Lithotripsy division was EUR4.8 million, or $7 million, reflecting the sale of 15 lithotripsy machines, including four high range Sonolith I-Sys devices.

Revenue growth in both the HIFU and Lithotripsy divisions resulted in gross profits of EUR10.7 million, or $14.9 million; up 17.3% from EUR9.1 million, or $13.4 million, reported in the full-year 2008.

Gross profit margin for the full-year 2009 increased to 43%, compared to 39.8% in the prior full-year period. The 43% gross margin rate was a five-year high, reflecting the positive scaling effect of added volumes and more favorable sales mix, with strong HIFU RPP sales and strong lithotripsy machine sales, and, more incidentally, a favorable exchange rate impact on the Japanese yen in the Lithotripsy division.

Gross profit in the fourth quarter 2009 increased to EUR3.7 million, or $5.4 million; up 11.9% compared to the year-ago period.

During the fourth quarter 2009, gross profit margin increased to 45.5%, up from 36.7% in the year ago period, primarily due to higher HIFU and Lithotripsy sales volume, and a more favorable product mix of Sonolith I-Sys systems.

Operating expenses for the full-year 2009 were EUR13.9 million, or $19.4 million, including EUR2.2 million related to the ongoing US FDA clinical trial, compared to EUR13.3 million, or $19.5 million, for the full-year 2008.

Operating loss for the full-year 2009 was EUR3.2 million, or $4.5 million, compared to EUR4.2 million, or $6.1 million, during the year-ago period.

The EUR1 million reduction in operating loss resulted primarily from the 17.3%, or EUR1.6 million, increase in gross profits, while the increase in operating expenses was limited to 4.6%, mostly due to sales and marketing efforts supporting increased volumes.

Excluding US FDA trial expenses, full-year 2009 operating loss narrowed to EUR992,000.

Net loss during the full-year 2009 was EUR7.8 million, or $10.9 million, or EUR0.74 per diluted share, compared to a net income of EUR1.6 million, or $2.3 million, or EUR0.17 per diluted share in the same period of 2008.

As stated in our press release, and as regularly discussed, since the inception of a convertible debt to finance the US FDA trials, the full-year 2009 net loss included a non-cash interest expense of EUR2.7 million, or $3.8 million, to reflect accounting adjustment of our convertible debt and outstanding warrants to fair value, compared to a EUR6.7 million, or $9.9 million, non-cash gain during the prior full-year period.

Entering 2010, we remain very encouraged by our strong cash position. At December 31, 2009, we had cash and cash equivalents, including short-term treasury investments, totaling EUR12.7 million, or $18.2 million.

In 2009, the Company's cash burn was reduced to EUR2.3 million, including EUR2.2 million for the US FDA trials, while operations outside the US were close to cash break-even.

Our cash position continues to leave us well funded to pursue strategic development projects, both in the US and in Europe.

Regarding our outstanding convertible debt, the recent increase in our stock price and trading volume after Japanese approval of Sonolith I-Sys resulted in the exercise of a portion of a convertible reducing total debt by $1.3 million to the current outstanding amount of $15.8 million. As a result, our balance sheet has improved, while our quarterly interest payments are reduced going forwards.

The repayments of our convertible debt remains a subject of very close attention by the management team, and we are currently working to find the best solution for every stakeholder of the Company.

With that, I would like to hand the call back to the operator to answer any questions you may have. Operator?

Thank you, sir. We will now be conducting the question and answer session. (Operator Instructions). Our first question comes from Matt Dolan with Roth Capital Partners. Please state your question.

Hi, guys, good morning. Thanks for hosting the call.

Hi, Matt.

First question; I guess now that we're essentially done with the first quarter, can you give us some feedback on your outlook for 2010, including maybe any backlog that you have entering the year? Typically, get that stat.

Yes, well, thank you for your question, Matt. As usual, and as you know now, we have some seasonality in sales. And usually, following a very strong quarter like Q4, Q1 is not as spectacular as the Q4 quarter, so the first three months of the year is starting as usual, slower than Q4. And we are working on building back the pipeline of projects as we again sold a lot of machines and concluded a lot of deals in Q4.

Okay, so what is your backlog now?

Well, the backlog of machines and RPP sales is, I would say, on plan, and starting the year being on plan and, again, following a very strong quarter, which is a little bit slower than Q4.

Okay. And maybe moving to I-Sys, can you talk about the outlook in the US for that product? Do you have an update on your sales strategy here? Is that a direct initiative or partnership, etc.?

Well, as we said and we described in press releases and in the script today, we have hired Jeff Howell to conduct the sales and marketing initiative in the US. He has a very, very important network and experience in selling lithotripsy as he's been in the business for the past 20 years.

We've sent a machine for demo purposes. And we are starting demos in the US and we are positioning ourselves in most of the deals. Now, I won't go in further detail as I don't want to disclose my sales and marketing strategy to the competition, but we are now extremely active, positioning ourselves in [most of deals] and being part of the market.

Okay, so you're hiring a sales force. Can you talk about how many and the expense associated with that?

Well, I won't give precise figures, but the expenses are very limited because it's only one person now in the US territory, and with very limited structure. So, it's about the same expenses as we would have in addressing this market from outside the US and France.

So, the strategy is single person direct sales presence?

Yes. And taking into account that the structure of the market in the US is 80% based on partnerships, and there are not thousands of partnerships, so one person with a very strong network, knowledge, and expertise of the market will very quickly cover most of the big players, and the big providers, and partnerships in the US.

Okay. Moving to ENLIGHT, can you talk more about the outlook here with FDA? Is the brachytherapy control arm going to be a reality soon?

And then, in your announcement I think you also talked about patient randomization in the follow-up period being topics of discussion, so can you expand on those issues?

Well, that's a good question, Matt. And as I just said, and in the script, we are in continuous conversation and meetings with the FDA. And we plan to have a specific communication on this subject somewhere at the end of April as we are in the middle of our reflection then, and go from that.

Okay. How much are you budgeting for ENLIGHT this year?

Well, it does not make sense to give you some budget figures right now because it will obviously depend on the final decision we make on the ENGLIGHT study by the end of this month.

Okay, so what are the key elements in that decision? Where does cost become prohibitive?

We won't -- again, Matt, we won't -- because we are not in a position to give further details as we are again in the middle of discussions, and meetings, and some higher negotiations so that we can come out and communicate clearly on a specific plan for the FDA within a few weeks. So, we won't disclose more information now.

Okay. Do you still expect the HIFU arm to be fully enrolled by around mid-year?

Well, as I said earlier today, again, we are continuing to enroll patients on the HIFU arm and, again, we are trying to maintain the momentum we have on that specific arm. But, again, we'll have a very clear detailed and complete communication within three to four weeks from now.

Okay. Thank you.

You're welcome, Matt.

Thank you, Matt.

Thank you. (Operator Instructions). Our next question comes from [Mark Weindling] with Paulson Investments. Please state your question.

Hello. I have actually a few questions today. And, number one; I guess I'm a little confused on some of your percentage increases. I look back at your 2008 annual report, and I believe it was 2005 that you changed your model from a revenue-based standpoint where you started with RPP.

So, taking that into account, and looking at the revenues that you show for 2009 of EUR24.9 million, in 2005 you show in your annual report EUR20.8 million. Just doing a quick calculation, that looks to me as if you've averaged just under 4% revenue growth for the last five years; do you consider that growth?

Mark, I don't have the 2005 figures with me but I'm assuming you're correct, but --

I just pulled this from your 2008 20F. It just said your total revenues in euros was EUR20.81 million, and so, just doing a quick calculation, that works out to 3.94% annual revenue growth as an average. Do you consider that growth?

Well, again, we're growing about 8% this year, which we believe, in the current economic environment where a number of devices companies actually reduced their revenue by a few percentage points, it's not a bad result actually.

I'm confused with the 8%. So you think you're going to do 8% growth this year, which is double the growth that you've done on average for the last five years, is that correct?

No, no, I was quoting the increase we had from 2008 to 2009.

Okay, I see. All right, that was my first question. The average annual growth in medical devices, by the way, is about 15% a year, so I just -- it seems to me that growth should be a little more rapid.

I have some concern about what is going to go on with medical devices in the US. According to a company called Frost & Sullivan, the US represents about 45% of all the global medical device market. And if there is a problem with HIFU coming into the market, essentially EDAP's going to give up almost half of the growth in the world. That seems to be a real problem for me, which really leads to my next two questions.

The first one is my understanding is that the Medical Director for EDAP is one of the primary -- one of the primary responsibilities for the Medical Director is the HIFU trials; am I correct with that?

Absolutely.

Could you explain to me what your thought process is then getting a Canadian physicist, who's never completed an FDA trial, to taking it to completion, working with the FDA. It just seems to be somewhat of a [non-secular] to me. Could you please explain why you have such confidence in what he's done to date, particularly given the results to date?

Well, I believe, Mark, you've asked this question in a conference call earlier, and we answered, and I will answer the same, is that you are obviously speaking about our Medical Director, John Rewcastle. And as I said, John has been working in the US for the past 10 years. He has been involved in several FDA projects.

And he is probably one of the -- and he was announced again in Washington DC back a month ago as one of the PhDs having the most number of publications on prostate cancer worldwide. So, he is recognized not only in the US but internationally by the urology community, including the American Urology Association and the European Urology Association, as one of the most expert in terms of scientific knowledge and clinical writing and publication background in the field of prostate cancer.

And I believe that's, for us, enough to have someone that is a complete expert in, again, reviewing and following prostate cancer trials and studies.

Thank you. (Operator instructions). Our next question comes from Jonathan Schwartz of Deerfield Limited. Please state your question.

Good afternoon, gentlemen.

Good afternoon, Jonathan.

I got on the call a bit late so I apologize for this question, but could you just give me any color that you gentlemen have given us on where we stand with ENLIGHT, with the second arm of the FDA trials?

Well, as we just said earlier today is that we are getting continued discussion from [discussion] and meetings with the FDA. And we plan to have more specific communications towards the US ENLIGHT clinical trials before the end of April. As we are in the middle of the discussion, so we won't disclose too much information on that.

And as we said earlier as well during the conference call is that we are -- in the meantime, that we are discussing with the FDA; we are continuing to enroll patients on the HIFU arm; and we are making all efforts in communications to maintain the momentum in recruiting patients for the HIFU arm.

And what are we up to now, Marc? What's our number of enrollees?

Well, we have treated now so far 112 patients. And we have some few cases that that are scheduled for the first week of April; we have already three cases or four cases scheduled. And we have around 30 patients in screening so far, and those 30 patients in screening are made in about 10 active sites.

Right, great. So, that's picked up?

Yes.

Have there been any --? The doctors -- the growth in RPP, I presume, is coming primarily from our core markets, from the hospitals in Munich, and in Lyon, and in Italy, and so on, and from existing doctors who are doing this, who are carrying the ball. Has there been any significant adds of doctors in our core markets, in France, in Italy, in Germany, outside the ones who have been with us all along? Or is that something that just is going to take more time to get people to appreciate the benefits of HIFU?

We are continuing to get new articles on the -- using our RPP models. And actually, most of our senior sites, like Munich and Lyon, are not RPP users as they have their own machine, because, again, they drive a volume number of studies (technical difficulty) they have bought the machine.

And as I said earlier, that you may not -- you were not present on the call, is that we've got some good RPP users that are converting themselves from RPP use to a machine. And to purchase the machine, we have two [articles] like this at the end of last year; one in [Zurich] and one in Pordenone in Italy. And again, we continue to create adoption among the urology community, and we continue to recruit new RPP sites.

Right. So, there have been some conversions? That's very -- that's positive because that means obviously volumes are up and people expect volumes to stay up.

How will the possibility of a 10-year study when we get to 2011 play out? We'll have 10 years; how will that work? Will some of the same people -- will, Thueroff and Chaussy, or some of the others who've written peer review studies in the past, prepare new studies for publication in urology journals with 10 year results?

Well, we are working on getting more and more, and as much as we can, long-term publications and communications. And [obviously], we come from the first centers that were using HIFU as they will be the only one to get and to achieve such a long-term type of data. And as we also communicate in previous press releases, we have now organized and set up a complete registry that most of our users in Europe and worldwide are now putting their data inside. So that will help, and that will definitely contribute in publishing new data and also long-term results, so we are working on that actively.

Right. So it's reasonable to assume that in 2011 there will be some peer review studies that will appear with what will then be considered long-term; 10-year data, right?

That's the target we have in, again, publishing as soon as we can these types of papers.

Yes. And is there any speculation, is there any feedback from the urology community, that when 10-year studies are finally published the heavens will open and lightning and thunder will appear, and they will finally say this is something that is now not investigational, and it's proven, and there'll be some movement by some of the doctors that haven't adopted to move our way? Or is this all just the sort of thing that I dream about at night, and maybe you do, and it's very speculative?

Well, I think, and I believe a lot of people think as well, that publishing long-term data will definitely help to create more adoption and to convince completely, and by giving them clinical evidence, new user for HIFU that have been waiting for those data to be released and published. And again, that's one of the reasons why we are working on data and long-term results, so that we can get those data to be accessible in the market so that people could have them.

The Company's cash burn in 2009 was EUR2.3 million but our cash position was not down by that much, was it? Did I do the numbers wrong? It looks to me as if cash is pretty --

Yes, it was actually, Jonathan. As compared with December 31, 2008 --

It was down by that? Yes, the figures should balance, shouldn't they?

Yes. On a 12-month basis the cash run was EUR2.3 million. And I was noting in my comments, most of it -- actually, EUR2.2 million was linked with the US trials, which means that the operations outside the US trials were very close to cash break-even.

Right. One last question, Marc. With this little run-up in the stock, was there any additional conversion of the converts, of the debentures to stock?

Yes, there were some more converts -- conversion. And we have now a total debt of $15.8 million, instead of $20 million at the beginning.

$15.8 million. And we came down from, what was it, $17.5 million or $17.3 million?

Yes, we came down $1.3 million.

Down $1.3 million. And was there conversion by more than one -- how many bondholders are there now? Are there three; are there more than three?

We still have the same number of bondholders as in the beginning; that means four.

Four bondholders. And was this conversion by more than one, or was it only by one?

By one.

By one bondholder. Well, thank you very much.

Thank you for being on the call, Jonathan.

Thanks.

Thank you. There are no further questions at this time. I'll turn the conference back to Philippe Chauveau for closing remarks. Thank you.

Thank you, operator. It's now my duty to officially close the call. Thank all the people who listened and who asked questions, and look forward to our next conference call for Q1 results. Thank you very much, and over and out.

Thank you. This concludes today's conference. You can disconnect your lines at this time. Thank you for your participation.