EDAP TMS's CEO Discusses Q4 2012 Results - Earnings Call Transcript

Apr. 2.13 | About: EDAP TMS (EDAP)

EDAP TMS S.A. (NASDAQ:EDAP)

Q4 2012 Earnings Call

April 2, 2013 8:30 AM ET

Executives

Stephanie Carrington – The Ruth Group

Philippe Chauveau – Chairman

Marc Oczachowski – Chief Executive Officer

Eric Soyer – Chief Financial Officer

Analysts

Suraj Kalia – Northland Securities

Ian Richardson – MA Capital

Craig Pieringer – Wealth Capital Management

Operator

Good day and welcome to the EDAP Fourth Quarter 2012 Conference Call. All participants will be in a 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.

And I would now like to turn the conference over to Ruth. Please go ahead.

Stephanie Carrington – The Ruth Group

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 over the call to Mr. Philippe Chauveau. Philippe?

Philippe Chauveau

Good morning, everyone and thank you for joining us on our fourth quarter investor conference call. We are the fastest growing lithotripsy company in the world because of the capacity for innovation that we have shown in the past few years. This record of innovation combined with a strong and aggressive market penetration strategy has led to a record quarter and a year for EDAP.

As we continue to expand our presence around the world, we believe this positive trend will continue. Our strong cash position at the end of the year is strong and will heading for 2013. With our Ablatherm PMA filing accepted, we look forward to working closely with the FDA in the months to come.

Now I would like to hand over to Marc.

Marc Oczachowski

Thank you, Philippe and thanks everyone for joining our fourth quarter and year-end 2012 earnings call. I will be reviewing recent developments across our business segments and then turn the call over to Eric to discuss the financial results.

Before starting the review, I would like to share my excitement and enthusiasm as we enter 2013. EDAP has achieved made significant milestones over the past year, almost without exception, the economic circumstances in the countries we operate in remain green.

Yet with tremendous energy and effort for all the EDAP team members around the world, we achieve significant growth in revenues concluded the following phase of our HIFU clinical trial and in January 2013 completed and submitted our PMA application to the FDA. 2012 has been an extremely positive year for a company and we are looking forward to an exciting and successful 2013. We by the way have already recorded a confirmed backlog of 13 lithotripters and one Ablatherm-HIFU machine in Q1 of this year.

Let’s review the details of our achievements and how they set the stage for the company’s future developments and success. 2012 was a record-breaking year for EDAP as we had record fourth quarter revenue and record full year revenue driven by record lithotripsy sales. We attribute most of this success to a strategy to having a wide range of products that added to most of the market segments and enabled greater market penetration.

The first part of this strategy was to extend our sales network both through direct sales and through regional distributors in all types of markets. We began implementing this strategy in the United States two years ago and we have increased the program’s aggressiveness in 2012 by acquiring more resources and continuing to structure our lithotripsy operations to effectively address this important and substantial market.

We also expanded our network of distributors to increase our presence in many of the markets around the world. This has allowed us to vigorously position our renewed range of products in most markets around the world. Not only that’s as to increase our business by more than 60% in the last five years, but it has also given greater revenue diversification and reduced dividends on any given country thereby reducing our country exposure in a competitive world environment with some regions in some form of financial crisis at any given time.

As we continue to penetrate more countries, we can easily compensate for lack of activity in southern regions by being very active and successful than others. Specifically, 2012 was a great year for our operations in Asia and operations gained significant traction in the Middle East too.

The second part of our expansion strategy was to build a range of innovative products that is broad enough to cover most of the market segments. This is clearly what we achieved with the current range of lithotripters including our Sonolith i-move and Sonolith i-sys. They represent not only the most innovative offering on the markets, but also the widest range of options and solutions.

Our relentless dedication to innovation and our extracorporeal lithotripsy offerings in some of these lines provides confidence that EDAP is well positioned to continue the growth planned around the world in the quarters ahead.

Turning to our HIFU division, I am pleased to say that last week we received notification that our PMA for Ablatherm-HIFU as a treatment for low risk, localized prostate cancer has been assessed for completeness and has been officially filed with the FDA. This notification came less than two months, 49 days to be exact, after we submitted the complete application to the FDA.

With this major milestone completed, we have now entered the substantive review phase for Ablatherm-HIFU. Completing the application was a huge effort for the company. That two year follow-up phase was completed at the end of last August after which we gathered all patients’ files from our 14 investigational sites in the US and Canada.

Our team worked very diligently day and night to compile the file so it could be submitted to the FDA in late January 2013. Let me comment further there, as some people may not realize the quantity of work needed to deal such a complex and technical file. It takes a lot of time and significant resources to make sure it adheres all of the rules and regulations and also provides the agency with all documents, data and details needed for them to perform a substantive review.

In addition to being complex, the quantity of documents needed to answer all of their required sections of the PMA is very significant. I would like to point out that it would even take too much time to count the exact number of pages in the filing and as a reference point, the FED expertise show they have found ways for completed PMA filing that was sent as an original copy to the FDA on January 31.

Since the start of our clinical trial, we are pleased to maintain close communication with the FDA. We will continue to provide the agency with the timely communication in order to support their review process. We recently announced a new addition to our HIFU offering. A new robotic HIFU device for focal therapy of prostate cancer called Focal.One.

Focal.One is the first device dedicated to the focal approach for prostate cancer therapy. The device combines the three essential components through efficiently perform a focal treatment. One is the state-of-the-art imaging to localized tumors with the use of Magnetic Resonance Imaging or called MRI, combined with a real-time ultrasound. Two the utmost precision of HIFU treatment focused on identified targeted cancer areas only and three the immediate feedback on treatment efficacy utilizing Contrast-Enhanced Ultrasound Imaging.

Focal.One brings ultimate dynamic focusing HIFU technology that allows physicians to create very small lesions, five millimeter long within the prostate without damaging surrounding tissue. This allows precise confirmation of the ablation volume and the target volume containing the cancer and allows for the preservation of add much prosthetic tissue as desired.

We officially launched Focal.One at the 28th Annual European Urology Association Congress in Milan, Italy last March where we saw tremendous interest in the device. For most of the exhibition, there was a huge queue to see the machine and the reception was very positive.

Focal.One in combination with our existing Ablatherm device provides the company a full range of HIFU offering. This is in line with our global strategy of covering most segments of the markets within which we operate. It allows us to expand our business and answer the treatment needs of all types of urologists and patients.

Positioning of both EDAP HIFU devices is clearly established as Ablatherm HIFU is an alternative to surgery with comparable efficacy results and with reduced side-effect profile. Focal.One is a complement to surgery as it provides a unique and dedicated solution for focal treatments, something not feasible with radical surgery or other radical treatments.

So again, by combing both products, EDAP is well positioned to expand its prostate cancer market penetrations and provides technical solutions to a wide array of technical circumstances for contemporary and future prostate cancer patients as the market shifts towards quality of life preserving treatment opportunities. This is a unique offering and it will certainly contribute to further recognition and acceptance of HIFU as a must have tool in the urological tie ups.

In closing, I would like to highlight not only the record revenues we recorded this quarter and in the full fiscal year, but also the strong cash position we have at the end of 2012. We are well positioned to continue expanding our leadership presence around the world, support the Ablatherm-HIFU PMA application review process forward in the US and launch together.

With that, I would now like to turn the call over to Eric who will review our fourth quarter and full year 2012 financials in more detail. Eric?

Eric Soyer

Thank you, Marc and good morning everyone. I will now take a few minutes to review our fourth quarter and full year 2012 financial results. Total revenue for the fourth quarter 2012 was €9.4 million of $12.3 million, a 25.3% increase, compared to €7.5 million or $10.1 million for the fourth quarter of 2011 and a 66% sequential increase, compared to €5.7 million or $7.1 million for the third quarter 2012.

For the three months ended December 31, 2012, total revenue for the lithotripsy division was €7.1 million or $9.3 million, compared to €5.8 million or $7.8 million during the year ago period. During the fourth quarter 2012, the company recorded sales of 21 lithotripsy machines comprised of eleven Sonolith i-move devices, seven Sonolith i-sys devices and three Sonolith Praktis devices, compared to a total of sixteen devices sold in the fourth quarter of 2011.

Total revenue for the HIFU division was EUR 2.3 million or $3 million for the fourth quarter of 2012, compared to €1.8 million or $2.4 million for the same period last year. Results for the fourth quarter 2012 reflected the sale of three Ablatherm-HIFU devices, as compared to one device sold in the same period last year.

Gross profit for the fourth quarter 2012 was €3.9 million or $5.1 million, compared to €2.8 million or $3.8 million for the year ago period. Gross profit margin was 41.3% in the fourth quarter 2012, compared to 37.2% in the year ago period. The change in the gross profit margin was mostly attributed to increased sales volumes.

Operating expenses were €3.6 million or $4.7 million for the fourth quarter 2012, compared to €3.2 million or $4.3 million for the same period 2011. Operating profit was €254,000 or $331,000 for the fourth quarter 2012, compared to an operating loss of €371,000 or $500,000 million in the fourth quarter of 2011.

Net loss for the fourth quarter 2012 was €1.1 million or $1.4 million, or €0.06 per diluted share, as compared to a net loss for the fourth quarter of 2011 of €579,000 or €0.04 per diluted share. Net income for the fourth quarter 2012 included a non-cash interest expense of €439,000 to adjust the Company's outstanding convertible debt and warrants to fair market value.

Turning to the results for the full year 2012, total revenue was €26.1 million or $33.7 million, a 16.9% growth year-over-year, as compared to €22.3 million or $31.2 million for the full year 2011. 2012 revenue included the sales of 52 lithotripsy devices and 4 Ablatherm-HIFU devices.

Gross profit for the full year 2012 was €10.4 million or $13.5 million and operating loss was €2 million or $2.6 million, compared to €8.9 million or $12.4 million and €2.5 million or $3.5 million, respectively, for the same period 2011.

Net loss for the full year 2012 was €7.5 million or €0.43 per diluted share. The full year 2012 net loss included a non-cash interest expense of €4.0 million to reflect the accounting non-cash accounting impact of the January 2012 exchange offering on its convertible debentures and related warrants. The reduction of the outstanding non-convertible debt and fair-value adjustments of outstanding warrants.

At December 31, 2012, cash and cash equivalents, including short-term treasury investments, were €8.1 million or $10.7 million. The Company's cash flow was stable in the fourth quarter.

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. (Operator Instructions) Our first question comes from Suraj Kalia of Northland Securities. Please go ahead.

Suraj Kalia – Northland Securities

Good morning Marc and Eric. Congrats on a nice quarter.

Marc Oczachowski

Good morning.

Eric Soyer

Good morning. Thank you.

Suraj Kalia – Northland Securities

Pardon to background noise Marc. So Marc, and Eric, could you give us an idea about the geographic split of the volume on litho machines sold in the quarter?

Marc Oczachowski

In the quarter, it was anecdotally, in the quarter the sales for the full year we had quite a focus in Asia first, as it was a very dynamic market for the year. And of course we started to get traction in the US.

Suraj Kalia – Northland Securities

And Marc, what is your expectation for a timeline for HIFU panel that be a panel?

Marc Oczachowski

Well, again it’s very difficult to set any execution there as again in the end of the FDA and what we’ll do is, we’ll again provide as much support and communication as possible to the agency so that we have been moving forward as fast as possible, but there is no precise guidance to the FDA for setting up the final reading. So, we won’t give any expectation there.

Suraj Kalia – Northland Securities

And finally, Eric, in terms of the 13 lithotripters what I heard are on backlog and the one HIFU machine. Can you give us a perspective on, for example, last year, when you exited with a certain backlog, what was the final realized units (inaudible)? Just trying to get a perspective on the outlook for Q1.

Eric Soyer

Backlog; sort of obviously don’t remember for us, if I am right, I believe we sold five lithotripters in first quarter last year.

Suraj Kalia – Northland Securities

Great, thanks for taking the question guys.

Operator

(Operator Instructions) Our next question is from Ian Richardson of MA Capital. Please go ahead.

Ian Richardson – MA Capital

Hi, gentlemen, how are you?

Marc Oczachowski

Hi, good morning.

Ian Richardson – MA Capital

Sorry, if I missed the answer to this question. But did you say how long the expectations were for the FDA at the current approval process? Did you say how long do you expect it to-date?

Marc Oczachowski

No, we did not, because, again, that’s in end of the – the question that arise was if we could have any expectation on the date or the panel meeting and of course we don’t – and there are no guidance given by the FDA on that. So…

Ian Richardson – MA Capital

Okay.

Marc Oczachowski

Again, on our side, what we’ll do is, we’ll continue working very closely to the FDA to provide them with any data, any information and details that they need to go as fast they could in reviewing the facts.

Ian Richardson – MA Capital

Okay. Then my last question, what part of the world do you see the most growth coming the future, Africa, South America, where do you see some emerging markets that you would like to get into?

Marc Oczachowski

Well, I think that’s the strategy to continue penetrating and expanding in most of the international markets and we recover quite a lot of countries today, again, as Eric said earlier, one of the very dynamic region today is Asia as Europe is still active but a little bit under crisis. So it goes a little bit slower than usual and again, one of the efforts that we have done and we will continue to do is to expand and get market share in the US.

Ian Richardson – MA Capital

Okay. Great. I appreciate. Great job guys.

Marc Oczachowski

Thank you, so much. Thank you.

Ian Richardson – MA Capital

Thanks.

Operator

And our next question is from Craig Pieringer of Wealth Capital Management. Please go ahead.

Craig Pieringer – Wealth Capital Management

Bonjour, Marc, Philippe, Eric.

Marc Oczachowski

Bonjour, Craig.

Craig Pieringer – Wealth Capital Management

So remind me please, what is the competitive landscape in the United States specifically for HIFU. I mean, the Ablatherm will be the first HIFU machine approved for use in the United States, is that true?

Marc Oczachowski

Yeah, it will most probably be the first device, the first HIFU device for prostate cancer to be approved in the US.

Craig Pieringer – Wealth Capital Management

And what is the status of the sono blade that used to be out there by focal surgery now known as US HIFU?

Marc Oczachowski

Yeah, it’s known now as sono catheter and they must chant again I think today. Well, we don’t really know it’s a private company, so they don’t communicate too much on the state of the trials. We just know that they started several protocol and technical studies and that’s one that really focused more of a salvage treatment of prostate cancer failures than the primary treatment of localized prostate cancer as we do. And we don’t exactly know where they are in terms of submitting to the FDA and getting it filed on that. So we don’t really know.

Craig Pieringer – Wealth Capital Management

Okay, thanks. And then secondly, the Focal.One sounds like a natural adjunct to the Ablatherm and you mentioned the release about going for CE Mark in Europe. It would seem natural that you would want to go for approval in the United States and what would be the possible timeframe for that as well?

Marc Oczachowski

Absolutely, and first that we love to get that Focal.One machine CE Marked in Europe and then we are going to start processing also other approval processes around the world and we will definitely consider the US taking into account that our focus today in the US is to really continue and complete the FDA process of Ablatherm and then discuss what are the possibilities and the possible ways to get the Focal.One approved as a complement of the range of HIFU products.

Craig Pieringer – Wealth Capital Management

Great, all right. Those are my two questions. Thank you. Good luck.

Marc Oczachowski

You are welcome. Thanks.

Operator

The next question is a follow-up from Mr. Suraj Kalia of Northland Securities. Please go ahead. And your line is live; perhaps it’s muted on your end.

Suraj Kalia – Northland Securities

Marc, can you hear me alright?

Marc Oczachowski

Yes.

Suraj Kalia – Northland Securities

Sorry about that. So Marc, obviously Ablatherm is not yet approved in the US. But in your discussions, the questions field feel people, are you recognizing that – again at least once the data point that we are gathering at prostate happenings are going down, especially it’s robotic process, when your field clinicians and your field people, are you all getting a sense as clinicians and you know what, I need (inaudible) much were waiting and complete prostate lesion and this might be one. Are you picking that up right now?

Marc Oczachowski

The line is very bad, so I didn’t really get the point of your question.

Suraj Kalia – Northland Securities

Sorry about that Marc. What I was asking is, are you picking up in the field since prostate (customers) are going down, clinicians (inaudible).

Marc Oczachowski

The line was really bad.

Operator

And it seems that line has disconnected. So at this time, I would like to turn the call back over to management for any closing remarks.

Philippe Chauveau

As there are no further questions, I believe, I would like to close this conference call and thank everyone for participating. So, over now, thank you so much.

Operator

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

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EDAP (EDAP): Q4 EPS of -EUR0.06. Revenue of $12.3M (+25.3% Y/Y). (PR)