EDAP TMS S.A. (EDAP) Q1 2015 Earnings Call Transcript
Published at 2015-05-13 11:52:09
Lee Roth – Investor Relations Philippe Chauveau – Chairman Marc Oczachowski – Chief Executive Officer Eric Soyer – Chief Financial Officer
Stanley Mason – Private Investor Swayampakula Ramakanth – H C Wainwright
Hello and welcome to the EDAP TMS First Quarter 2015 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 that this event is being recorded. I would now like to turn the conference over to Lee Roth. Mr. Roth, please go ahead.
Thanks, Keith. Once again thank you for all joining us, and good morning. With me today from the company 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 both prepared and then response to your questions may contain forward-looking statements. These include statements regarding the company’s growth and expansion plans. And such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual performance differ from those described in such forward-looking statements. Factors that may cause such a difference include, but are not limited to those described in the company’s periodic filings with the U.S. Securities and Exchange Commission. With that, it's now my pleasure to turn the call over to EDAP’s Chairman, Mr. Philippe Chauveau. Philippe?
Thank you, Lee. Good morning and welcome to EDAP’s Q1 2015 conference call everyone. I have brief opening remarks to share with you. First in Q1, we grew procedure-driven revenue from the HIFU division by 17% year-over-year. Second, after the end of the quarter we submitted our Direct De Novo 510(k) petition for Ablatherm HIFU to the FDA and it is now under review. And third we continue our prudent cash management. Now, I’ll turn over the call to Marc. Marc?
Good morning everyone and thank you for joining us on our first quarter 2015 conference call. Overall the first quarter was relatively consistent with our Novo and expected business cycle. Total revenues were down from the first quarter of 2014, which speak to the size that the year ago period was an exceptional one for the company with five HIFU systems sold. The key takeaway from our first quarter of 2015 results was the 17% increased in procedure-driven revenue from the HIFU division compared to last year. This revenue item which relates to the total number of treatments using devices in the field is a reflection of our growing adoption of HIFU, and a clear sign that the technology is being accepted by an increasing number of urologists as a viable therapeutic option for prostate cancer patients by both size and effective. We continue to develop and enhance our sales marketing and clinical capabilities with a goal of maximizing or installed base the Ablatherm and the Focal One systems and centers. We remain intensely focused on driving adoption of the technology and grow the average number of procedures perform on each of installed system around the world. At the beginning of the year we’ve reached an important milestone with the approval of Focal One by Health Canada, and our first systems sales Jewish General Hospital in Montreal. Jewish General Hospital is one of the leading institutions for the treatment of prostate cancer in Eastern Canada and I’m pleased to report that their Department of Uro-Oncology led by Professor Franck Bladou has successfully treated patients since the next generation HIFU system was placed. This is an important reference site for us as we continue working to extend our footprint in the Canadian market. Bringing our HIFU technology to the U.S. via FDA clearance of Ablatherm remains our top priority. On our last we discussed our intends to file the De Novo petition for Ablatherm HIFU based on the tool claim with an indication of prostatic tissue ablation at this succession of FDA [ph]. I’m pleased to report that in line with this plan we submitted our Direct De Novo 510(k) petition to the FDA after the close of the first quarter. This De Novo petition is now under review by FDA and we look forward to receiving feedback from the agency and continuing the regulatory process. As already explained, the FDA has 120 days to review a De Novo file, although in practice it may take longer to complete the review depending on the number of comments and questions we might receive from the agency during this in-directive review process. In addition we were granted a six months extension on the filing of our PMA amendment for the treatment of intermediate risk prostate cancer patients. As we have previously discussed both [indiscernible] are being kept up on to maximize our regulatory options. According to the National Cancer Institute, there will be an estimated 221,000 new prostate cancer diagnosis in the U.S. this year, accounting for roughly 13% of all estimated cancer diagnosis in the U.S. Moreover, there are an estimated three million American men currently living with the disease. Prostate cancers increase prevalence among all the men population is expected to grow as a result of the overall aging population. If we receive marketing clearance from FDA, U.S. urologists may adopt our HIFU technology at the rate greater than what we have achieved in other regions, creating an immediate and substantial commercial opportunity for EDAP. As you may be aware the 2015 Annual Meeting of the American Urological Association or AUA will begin later this week. And EDAP will be well represented adherence [ph]. One of the highlights will be the presentation of the multi-center [ph] long-term study including more than 1,300 patients with intermediate risk prostate cancer who were treated with HIFU. The 10-year prostate cancer specifically survival rate was 98% and metastasis-free survival rate was 93%. These outcomes are similar to that of radical prostatectomy and were achieved with the mild mobility profile. For example, when the Ablatherm Integrated Imaging device was used the great two or three incontinence rate was only 4.5%. HIFU is the primary driver of our future growth, but our lithotripsy products continue to be an important and stable contributor to our business. Total revenue from the Lithotripsy division was €4.6 million, an increase of 3% over the first quarter of 2014. Our OEM partnership with Quanta System in Italy is processing according to plan and we will be selling our EDAP branded urological stone lasers through our global distribution network. These devices are an excellent complement to our industry-leading portfolio of lithotripsy products and we are confident that this relationship will benefit both parties and would allow EDAP to continue strengthening its leaderships in technologies for the treatment of urinary tract stones. Finally, I’d like to say a few words on project to extend HIFU technology to the treatment of liver tumors. As we recently announced, EDAP would participate in the HECAM consortium led by GE Healthcare with the goal of developing new solutions for early diagnosis and treatment of both primary and metastatic liver tumors. EDAP’s participation in this major project is based on a world-class expertise in HIFU and our close partnership with prominent academic and clinical centers in this field. The clinical results of our previous Phase I-IIa study for the treatment of patients with liver metastatic disease using HIFU were recently published in the peer-reviewed scientific journal PLOS ONE. The study using HIFU as non-invasive tool in a often surgery procedure concluded that this new more powerful HIFU device was able to safely and effectively ablate large volumes of liver tissue in a short period of time, and with a precession of one millimeter or two millimeters and the real-time ultrasound monitoring. These results are very promising and we now plan to move forward into the Phase 2b of this clinical study in an effort to further establish HIFU’s benefits for the treatment of liver tumors. In summary, the first few months of 2015 were important for EDAP and we are well positioned to continue advancing in several key strategic areas. We achieved strong growth in positive driven revenue in the HIFU business providing clear evidence of the increasing utilization of our installed systems to treat patients. Second, we completed as planned our De Novo petition for Ablatherm HIFU and submitted it to the FDA [ph] to initiate the review process. And finally, we continued our pipe management of expenses and finished the quarter with a strong cash position of €11.3 million As always, we thank you for your continued support and look forward to updating you on our future accomplishments. With that I would like to turn the call over to Eric to review the financial results. Eric?
Thank you, Marc, and good morning, everyone. I will now take a few minutes to review our financial results for the first quarter 2015. Total revenue for the first quarter 2015 was €6.2 million or $6.9 million, compared to €7.8 million or $10.6 million for the first quarter 2014, which was as Mark already mentioned, a Q1 record quarter for the company. Total revenue for the HIFU division was €1.6 million or $1.8 million for the first quarter 2015, which included the sale of one Focal One device, compared to €3.3 million or $4.5 million for the same period last year, which recorded the exceptional sale of five HIFU devices. As Mark noted, the HIFU division enjoyed a strong 17% year-over-year growth in placebo driven revenue in the first quarter of 2015. Total revenue for the little Lithotripsy division was €4.6 million or $5.1 million for the first quarter 2015, compared to €4.5 million or $6.1 million during the year ago period. Gross profit for the first-quarter 2015 was €2.6 million or $2.9 million, compared to €3.6 million or $4.9 million for the year ago period. Gross profit margin on net sales was 41.5% in the first quarter 2015, compared to 45.9% in the year ago period. Operating expenses were €3.2 million or $3.5 million for the first quarter 2015, compared to €3.0 million or $4.1million for the same period in 2014, the small increase mostly due to exchange rate variations. Operating loss was €622,000 or $689,000 for the first quarter 2015, compared to an operating profit of €558,000 or $765,000 in the first quarter of 2014. Net loss for the first quarter 2015 was €2.4 million or $2.7 million or €0.10 of Euro per diluted share, as compared to net income for the first quarter of 2014 of €840,000 or $1.2 million or $0.04 of euro per diluted share. Net loss in the first quarter 2015 included a non-cash interest expense of €2.4 million to adjust the accounting fair value of the outstanding warrants. Final words on cash, at March 31, 2015 cash and cash equivalents including short-term treasury investments were €11.3 million or $12.1 million, which is a Q1 cash utilization of €0.9 million which was mostly due to inventory replenishment. Thank you very much for your attention. And I will now turn the call over to the operator who will open up the line for questions. Operator.
Yes, thank you. We will now begin the question-and-session. [Operator Instructions] And the first question comes from Stanley Mason a Private Investor.
Good morning. Good morning Eric and good morning, Roth. First thank you for the visit that we had on April 23, visiting your facility which was very enlightening and it was a great think from my grandson, as well who is now an investor as well and we wish the company well. My question would be several, one is when was the FDA filing complete? I know it was compete at the end of the quarter but was that sometime mid-April or was it early April?
Well, it was in the month April.
In the month of April, okay. And have you had any feedback yet from the FDA with regards to questions and further information that they request?
Very good. And the increase in 17% increase in revenue on the HIFU division is that a factor with regards the French health system now paying for HIFU treatment?
Well that’s probably, I mean, the momentum on increasing the number of treatments in Europe was suddenly driven by the French market, but also the German market and the other markets in Europe. So it’s only the beginning and the French reimbursement is starting to be reclusive [ph] so it’s not fully – it’s not a full speed yet so we can expect better numbers from the French markets in the months to come.
Very good and once again I really thank you for the visit which was very enlightening and thanks, Glenn Dean and Emmanuel [ph], as well. As you know I’m a survivor from HIFU treatment and I truly believe in this procedure and wish the company well.
Thank you, you’re welcome.
Thank you. And the next question comes from Swayampakula Ramakanth of H C Wainwright.
Good morning, Eric and good morning, Mark. Hope you guys are doing well.
A couple of quick questions. One I know you are kind of doing the parallel last year [indiscernible] directing going on and the PMA going on, that’s what you we’re seeing in your comments. So in case, at what point they will become – one become, one exclude other or how does – how do you plan to keep two systems going?
The line is not too good [indiscernible]. But basically both projects are running in parallel and they don’t interfere one to the other because indications of the phantom [ph] and those of the process is different. So as we discussed on the last conference call and we repeated it today, we are keeping all options up and then working on both of them so that we maximize our chances.
Okay. And can you hear me better now?
Yes, it’s a bit better now.
Okay. So on the PMA you have an extension, so when does that extension end? And what’s the prod [ph] just there in terms of filing that?
Its extension is – they have cycles of six months. So if you remember, we announced that we had until end of April so we were granted a six months extension, which leads us to the end of October.
Okay. All right. And then it’s great to see that as soon as the Canadian markets got opened up for you, you got a sale in. So what’s the market there, I mean, what you – how you do expect this market to grow from here? And is the sale cycle there any different for anywhere else in the world?
Well, just a size of the market, I mean it’s kind of that with a population that is not huge though, but still it’s an interesting market for few reasons, one, I mean first, they are – there is a potential for a number of machines there that also it’s a key market as it is in North America and just the neighbor of U.S.A. And again I think it’s an important potential and opportunity, as well for American patient to be treated on the latest HIFU technology by going to Canada. So, for these both aspects it’s an important and a kind of strategic market for new technology that is not yet approved in the U.S.
Have you heard of any anecdotal – have you had any anecdotal information regarding American patients crossing the border over?
Yes, yes, there are plenty of those, I mean we know that HIFU machines that we have in Canada or in the Caribbean, I mean, most of the patients treated on those machines are from the U.S, we also a plenty of feedback from our European centers treating American patients. So there are a lot of patients, there are hundreds of patients crossing the border every year to be treated on HIFU, whether in the American continent or in Europe.
Okay that is fantastic. The last couple of questions on the liver that said, I think, that is a kind of an interesting aspect for the HIFU technology. First question there is are you the only folk looking into the liver tumor using HIFU or do you have other competitors working in the same indication?
Well to my knowledge we are the first to use the HIFU technology on liver tumors and that is a partnership we have with foreign academic centers and clinical centers, as well, here in France. And this is still a clinical stage but to my knowledge we are the first using HIFU to that application.
Okay. I apologize Mark, you did say the name of a journal, where some of the data was published, but I didn’t catch it. Would you mind repeating that, please?
Yes, it is PLOS 1, it is PLOS and then 1, one.
Okay, okay. And so this Phase IIb that you are expecting to get started, can you tell us a little bit more about the study, like what is the patient population you’re looking for? What is the end point? When would you start? How long would it take? Any kind of information will be helpful.
On that liver tumor, which you are extending into Phase IIb you said that you’re progressing into the next phase of clinical studies?
So I mean without spending too much time on that, I mean the first phase of the study was to show the capability of ablating liver tissue and that was proven. And again that’s the publication we’ve got on that. So I invited to read that publication, where you’re going to get all the details. And now the next phase is to see a sort of [indiscernible] in treating tumor, I mean liver tumor. So that’s going to be next and we can discuss about the details of that study but it is a regular study, I mean, including on one center to treat. Again and ensure the effectiveness of HIFU in treating liver tumors, not only liver tissue.
Okay, all right, thank you gentlemen.
Thank you. [Operator Instructions] All right, there are no questions at the present time. So I would like to turn the call back over to Mr. Chauveau for any closing comments.
There being no more questions I will now close today’s conference call. Thank you everyone for participating on today’s conference call, talk to you later bye, bye.
Thank you. The conference has now concluded. Thank you for attending today’s presentation. You may now disconnect.