SANUWAVE Health, Inc. (OTCQB:SNWV) Q3 2017 Earnings Conference Call November 21, 2017 10:00 AM ET
Executives
Lisa Sundstrom – Chief Financial Officer
Kevin Richardson – Chairman and Chief Executive Officer
Pete Stegagno – Vice President-Operations
André Mouton – Vice President-International Sales and Relations
Analysts
James Terwilliger – Paulson Investment
Brian Marckx – Zacks Investment
Operator
Good day, ladies and gentlemen, and welcome to the SANUWAVE Third Quarter 2017 Financial Results and Business Update Call. All lines have been placed on a listen-only mode. [Operator Instructions]
At this time, it’s my pleasure to turn the floor over to your host Lisa Sundstrom. Ma’am, the floor is yours.
Lisa Sundstrom
Thank you. Good morning. We appreciate your interest in SANUWAVE and in today’s call. SANUWAVE will now provide an update of our most recent activities during the quarter as well as our third quarter 2017 financial results. Our quarterly report on Form 10-Q was filed with the SEC on November 14, 2017. If you would like to be added to the Company’s distribution list, please call SANUWAVE at 770-419-7525 or go to the Investor Relations section of our website at www.sanuwave.com.
Before we begin, I would like to caution you that comments made during this conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of SANUWAVE. We encourage you to review the Company’s filings with the Securities and Exchange Commission, including without limitation our Forms 10-K and 10-Q, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.
Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, November 21, 2017. SANUWAVE undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.
With that said, I’d like to turn the call over to our Chairman of the Board, Kevin Richardson. Kevin?
Kevin Richardson
Thank you, Lisa. And thank you everyone for joining us on our call today. I want to first apologize for the delay in the conference call. Last week the team was in Germany for MEDICA and the other part of the team was in Canada for Wounds Canada, so logistically would have been extremely difficult to organize a conference call. The good news is we had an extremely successful shows both in Germany and Canada, we will discuss some of the details on this call. But we received our initial look for international orders for 2018 and regardless of FDA approval it should be a record year.
Today we will update you on the many initiatives SANUWAVE is undertaking. This will cover Q3 results, Brazilian update, FDA update including what we have done to prepare since our last call international initiatives, our wound symposium which is scheduled for early December and then some new initiatives as well.
I will finish with concluding remarks. Overall we remain positive about the FDA process and remain laser focused on preparing for wound care market entry in 2018, which is why we feel confident in hosting our first symposium. You will also hear us announce participation a number of medical conferences for 2018, we will be sharing abstracts and presenting posters first time in over five years. The journey has been long and we truly feel as if we’re coming out of hibernation and we’re prepared to take on the challenges now facing the wound care industry.
With that, let me turn it over to Lisa to review the financials.
Lisa Sundstrom
Thank you. Revenues for the three months ended September 30, 2017 were $162,000 a decrease of $94,000 or 37% from the prior year. Our revenues resulted primarily from sales in Europe, Asia and Asia-Pacific of our orthoPACE device and related applicators. The decrease in revenues for 2017 was due to lower sales of new orthoPACE devices and applicators in Europe and Asia-Pacific as compared to the prior year. Research and development expenses for the three months ended September 30, 2017 were $267,000 a decrease of $1,000 from the prior year.
General and administrative expenses for the three months ended September 30, 2017 were $475,000 a decrease of $171,000 or 26% from the prior year. The decrease for 2017 was due to lower legal fees, lower salary and benefits related to reduce headcount and a decrease in our bad debt reserve. Net loss for the three months ended September 30, 2017 was $851,000 compared with a net loss of $1.1 million in 2016 a decrease in the net loss of $289,000 or 25%. The decrease in the net loss for 2017 was due to lower general and administrative expenses and a reduction in amortization costs.
Looking at cash flows as of September 30, 2017, we had cash on hand of $40,000 compared with $134,000 at December 31, 2016. Net cash used by operating activities was $945,000 for 2017 year-to-date compared with $2.7 million from the same period in 2016. The decrease in 2017 cash used by operations was primarily due to lower operating expenses. We continue to project that our cash burn rate from operations will be approximately $125,000 to $225,000 per month in 2017 and as we continue to expand our international market, prepare for the commercialization of dermaPACE and continue research and development of non-medical uses of our technology.
Now, let me turn the call to Pete Stegagno for regulatory update.
Pete Stegagno
Good morning everyone. I’m going to address probably the one or two questions pretty much on everyone’s list. What’s happening with the dermaPACE de novo and the FDA review process? And do we have any idea of FDA decision and when will that be. And that three question but keep counting.
There has been a flurry of communications with the FDA over the past month particularly from the lead reviewer in the Medical Officer in the review team. We’ve been working on a document – the transparency document, which discusses the device, the indications, the warnings, precautions, contraindications, device function, trial data in very specific form and we have submitted all the requested data in the requested format.
Final cautionary statements have been completed and added to the use of patient labeling. We believe the review team is near or has completed their work. The next step is for the review team to submit the final transparency document to upper management along with their recommendation for review and final action.
At this point, we don’t know when the document will actually be moved up to chain, we don’t know how long it will take upper management’s review and approve and we don’t know what the review team’s final recommendation is. So all we can do is sit and wait and basically enjoy some turkey and football on Thursday.
We’ve done some calculating on the timelines of this de novo submission. It was submitted to FDA 15 months ago in July, 2016. We received their first set of questions in January of this year submitted our responses to those questions to FDA in July. And we’ve been working consistently with the review team since August. This package has been going through FDA’s clock for over 300 days now. Unlike PMAs and 510(k)s the de novo does not have a particular defined review period, although there is a draft guidance coming out shortly and they are recommending 120 day review period. We’re basically at the end of the process and we can only hope that a decision will be communicated to us shortly.
On a different note, we attended SAWC the symposium from advanced wound care in October and came away with some impressions and how we plan to move forward with dermaPACE. One is that there really isn’t any new device product on the market for wound care, the latest buzz seems to be the miotic base products and there are more and more providers coming onto the market. We believe that dermaPACE will be able to develop our nesh because of its clinical performance, it’s not invasive nature and its ease of use. We came away with a number of leads to follow-up on in regard to supplement in dermaPACE with supportive products and technologies including imaging and wound care management suites. We’re excited about what we can do once we hit the U.S. market and of course, the next 18, 24 months and beyond.
We’re looking forward to an active year in the clinical side for 2018, we’ve been lining up key researchers to collaborate with us and follow on DFU studies to support reimbursement for dermaPACE. We’re also planning on expanding indications for dermaPACE in such areas of Venous Leg Ulcers and other vascular and perfusion indications and also scarring. We expect to have results and publications from ongoing studies in Belgium were dermaPACE is being used in a home treatment setting and from South Korea were KOLs are using dermaPACE for DFU’s and interestingly scar reduction at c-sections.
We plan to continue this work in Brazil for both DFU and scarring with a new partner there. We’ve also breathe new license the Canadian market where we have partnered with wound care professionals to place dermaPACE with key wound care centers. Finally we have many distributors particularly in Europe, whom we will collaborate with an investigating use of our shock wave technology in treating erectile dysfunction.
With that said, I’ll turn it over to André.
André Mouton
Thanks Pete. Good morning everyone. During our last call, we guided and updated all the countries, we would like to emphasize that registration per country is a time consuming and ongoing process. We’re working very closely with our identified distributors to ensure and make this process as effective and smooth as possible within the required county regulation. South Korea is still our leading market. During our recent meeting in this regard at the MEDICA conference, our current distributor KOLs gave us more feedback on various studies they are undertaking in the wound care space and that’s agreed for ongoing trial data sharing and access to the key opinion leaders to ensure we maximize our own network between distributors.
We have the same positive discussions with Matec [ph] from Italy, also Medicor from Belgium and Prim from Spain. It became very clear that all our current distributors believed in the product and our focus on specific actions within the wound care market and that all the targets can be achieved. The positive meetings we had will be folded upward attendance at our training seminar in December and distribution of all the key opinion leaders, key findings within our distribution network.
We have finalized registration in Taiwan and are awaiting final stage in Rumania and Indonesia. These include taxes and listing of our product on the national standard programs per country. These activities will be followed up by the first purchases of the clinical demo units and/or outright commercial product sales. We have started the registration process in South Africa as well as registration of our orthopedic unit in Canada. Our regional discussions with identified targeted Southeast Asian distributors are still on track. We will also have direct communications with potential distributions by the biggest wound care player in Thailand.
During the recent MEDICA conference, we have made out with a lot more potential partners as we are now in the process of getting the paper work done especially the NDA’s to ensure that we share more detail. We have identified regional players in Europe and are now finalizing the shortlist for France, United Kingdom and Finland as well. The sales for distributors within Eastern Europe with key focused countries for wound care like Poland and Russia is still ongoing. Our Canada exposure has been increased by engaging a well known wound care nurse practitioner on a success fee basis.
[Indiscernible] the key opinion leaders as well as more insights within the government structure and their rules around purchasing. We also had a presence at recent Canada wound conference. We refer as well with one of our senior management members representing the company and demonstrating the dermaPACE device and functionality. We mentioned during the last call that we are shifting our focus for the Middle East, India and China given the size and market attention. There is current process of identifying groups we can work with as potential investment partners for that specific area is ongoing.
The recent success we had with Brazil is ARPU of these countries as well as the new discussions we started with Mexico. We must ensure that we ever would pick as a partner that will handle our distribution and our key opinion leader relationships must be inline with our overall focus and strategy. We are now following up and finalizing our target sales numbers for 2018 as we got from MEDICA from our distributors. Based on these initial feedbacks, it looks like it’s going to be a record year for us regardless of the ACA decision in 2018. We’re also planning to add more countries as partners before year and as we go through to 2018.
That being said I will turn the discussion back to Kevin for concluding remarks.
Kevin Richardson
Thank you, André. Concluding remarks today will be brief because the team has covered pretty much everything we wanted to cover today. Once we hear from the FDA, we will hold the conference call as it is clearly material. We did this when we announced Brazil and we will do so when we announced any deal of similar size due to the materiality. Q3 was focused on meeting FDA’s comments preparing for a successful commercial launch and interacting with the international partners. Pete spoke about the FDA and I’m sure in QA we can answer any questions as best we can whatever you ask.
We really cannot comment on commercial plans yet but we will discuss shortly after an approval. Internationally the big event Q3 was singing Brazil, the Mundi team is fantastic they have been interacting with our team constantly and all plans remain on track for a successful launch in 2018. And then Mundi’s also made their payments to us. So from a milestone standpoint we’re on track there.
In fact the Brazil team will be setting four people including two KOLs to our symposium, which will take place in two weeks. These are highly regarded doctors who will become part of the Mundi SANUWAVE launch in 2018. Regarding the symposium, we have had an overwhelming response, which is actually – we have to move the location because of the international demand. As many of you are aware in the U.S. we cannot market dermaPACE product until we receive clearance, this symposium is really an international event.
We originally thought we’d have eight to 10 participants, now we’re over 30. Countries represented are Brazil, Italy, Belgium, Germany, South Korea, Taiwan, Canada, Mexico and the Middle East. We also have researchers from Harvard University, University of Georgia, Chang Gung University, University of Illinois, King Saud University. The keynote speakers at this will be Dr. Wang and Dr. Seimienov. Dr. Wang is considered the godfather of shock wave, he runs a Shock Wave Institute in Taiwan. And he has published more studies on shock wave than any other doctor.
Dr. Seimienov is well respected for her work in plastic surgery and microsurgery. She was the person in the U.S. who perform the first face transplant. We will also have our partner Ecare presenting and the highlight for me at least will be discussing the various studies being performed using dermaPACE around the globe. 2018 will be a year when we make our presence known again, you’ll see many of our – these research papers and cases published in poster form and present in various wound forms.
Speaking of the wound forms, we plan to attend SAWC, EWMA, Korea Wound along with other internationally known wound forms in 2018. We are finally at the time when we can reemerge from hibernation to make great strides. Our product as Pete mentioned is the only new product in the wound market that is in great need of a way to increase vascularization. Finally, you will see us announcing new partners and new employees in the coming months. We have begun interviewing key professionals, which will round out our team and allow us to launch successfully in U.S. and build upon that for the future.
With that, let me open up to QA. Angelica?
Question-and-Answer Session
Operator
Thank you. The floor is now open for questions. [Operator Instructions] Okay. Our first question comes from James Terwilliger of Paulson Investment. You may now state your question.
James Terwilliger
Hey, Kevin. Can you hear me?
Kevin Richardson
I can hear you James. How are you doing?
James Terwilliger
I’m doing okay. Thanks for the update. I’ve got two or three questions real quick. First, remind me again on the timelines and the milestones on the Brazil deal in terms of when they kick-off and what should we see there, will there be any updates or press releases as we move into next year.
Kevin Richardson
Sure. So, the answer is yes. We’ll provide an update as we move forward. There’s an initial payment that was made October 6, so it was not recognized in the third quarter, we recognized in the fourth quarter. And then there will be monthly payments over 2018 and into 2019 as part of the upfront agreement. During that time period, the team here to at SANUWAVE will be working with the Mundi team to go through two processes and then these are process which is basically to get the product through their FDA. They’ve already selected the consultants they will be working with and then once that occurs we’ll be bringing it to market. We anticipate that to happen before the end of 2018, so approval sometime in probably Q3 or Q4 2018 and then commercial revenue being coming into the company through the joint venture in 2018.
Between now and then their KOLs will be coming to the symposium in December. They’ll be getting trained on the device, trained from the different clinical studies that are taking place internationally. And they’ll begin their own case work and clinical work so that they can be part of the KOL launch when the product officially kicks-off a year from now.
Part of that process it would found in other countries getting KOLs involved early is really important, so that they can have a reference site to point to when we launch commercially. The next announcements will have out of Brazil will be when we make – we’re making milestone payments but also when we have kicked-off the different processes whether it’s in visor or the different KOLs studies that they’ll be engaged in. So I think that’s kind of the game plan with Brazil. We’re hoping that we can mimic that in some other countries where we’re in talks with currently. Some are much larger than Brazil some are smaller than Brazil. So we’re using that as our guide post moving forward.
James Terwilliger
Okay. And then just very quickly on the clinical symposium. Do you have kind of a ballpark, I think it’s fantastic, but do you have a ballpark number of how many people would be there. I think it’s kind of –I don’t think it would be as big as what you indicated on the call.
Kevin Richardson
Yes. We did neither, our original hotels we booked were for kind of 10 people and we have a few speakers in. And the demand has been enormous. So we’re going to have over 30 participants, I think having Dr. Wang and Dr. Seimienov as keynote speakers really drew in a big part of this crowd. We’re seeing folks from the – it’s mainly our distribution partners are all bring in a doctor with them and it’s mainly their local market KOL but they’re bringing in that are doing case work already. So it’s turned into something that’s bigger than we expected we had to move hotels to get a bigger venue.
It’s really exciting, I mean, we’re excited about it, we’ve got from Italy Dr. Casino will be in, he’s got some case work that he’s been doing. Doctors from Berlin, South Korea, Brazil, Mexico it’s a really full audience with a full two day program. Part of it was just to set up, so we could quite frankly teach the Brazilians how to use the product as they launched from a KOL perspective but it’s really turned into having our science advisors and really working on our launch program for 2018 and 2019.
James Terwilliger
No, I think it’s fantastic, it takes time to do that with the KOLs, of course you are going to build some very strong relationships across your team and all your distributors and the clinicians as well. So I think that’s great. The last thing I want to ask about and I think it kind of raised my eyebrow. I think Pete said it, the de novo application has been in front of the FDA for 15 months is that correct?
Kevin Richardson
Yes. End of July, Pete said, it was submitted at end of July, they responded with their question first round of questions January of this past year. We answered those in July of this year and then it’s just been quite frankly informal back and forth. A lot of it’s just clarification and helping them with tables and things like that over the last few months.
James Terwilliger
And that’s not – that doesn’t include any change to the data set. I mean, you weren’t treating patients at this time…
Kevin Richardson
We are all done. The trial closed in September of 2015. I think our last enrollments were probably six months prior to that. So it’s – we’ve been – this has been a long process and it is not like we can’t change anything and they are asking other questions from can you look at it this way with age or your different levels of BMI or different levels of glucose, I mean is it just asking a lot of different question in different ways.
At the end of the day, they want to make sure it is a safe product and it is effective and from a safety standpoint we’re lights out on that front. And from an effective standpoint it all comes down to how you label and a lot of what we’re going to have to do as we move forward is working on, follow studies on profusion, vascularization, venous leg ulcers, other indications.
So we’ll have other work to do but getting the approval it’s about safety and effectiveness and luckily we have both. And so, I think we’re going to be pleasantly surprised soon. But it’s the FDA. So as you know James it’s, once it moves up to that next level, I don’t know if it’s going to be a week or a month or two months.
James Terwilliger
No, I mean it is out of your hands. They have a job to do too and I respect their job. I just didn’t realize it was 15 months, not that I didn’t know that, I just – time goes so fast you don’t realize.
And then once you do get approval, if you do get de novo approval, and I believe you will based on my research but everything from here in terms of expanding indications, it would all be 510(k)s correct based on this de novo approval.
Kevin Richardson
Pete, I will let you answer that just because I don’t want to misstate but that I believe correct. So go ahead.
Pete Stegagno
The actually the proper – even I’ve been using the wrong term. The proper term is clearance. So if FDA does agree to this de novo we will actually be cleared as a Class 2 device and therefore providing we don’t stray too far from current indications hopefully all updates and improvements will be 510(k).
James Terwilliger
And those are a little bit a little bit easier to get. I’ll stop and jump back on queue. But thanks Pete, thanks Kevin.
Kevin Richardson
Thank you James.
Operator
Thank you our next question comes from Brian Marckx of Zacks Investment. You may now state your question.
Brian Marckx
Good morning Kevin.
Kevin Richardson
Good morning Brian.
Brian Marckx
I wanted to ask you about current sales. It appears that you guys have been making good progress in adding new distributors in different territories and making progress on regulatory approvals in various different countries. But for whatever reason it doesn’t seem to be that that is translating necessarily into revenue. And I think your expectation on earlier calls were that we would see, I guess more significant revenue through 2017 than we have so far.
So if you can kind of just, I guess help us understand kind of what the disconnect is between expanding – expanding essentially your distribution footprint, and then your expectations of greater sales during 2017 and then kind of what we’ve actually seen.
Kevin Richardson
Sure. Good question, good observations. The first thing we talked about this year was just expanding our footprint with new countries. And we stated our goal of this year between seven and ten new countries added. We’re at six, right now. I’m confident we’ll be adding between seven and ten. As we’ve mentioned before the process when you do that is you’ve added a new country and then you have to get the product registered, and then you get a KLO involved. So as we said in the fourth quarter call, first quarter call, second quarter call, it takes about six months or nine months to ramp up a country.
And I think probably, I think, where the disconnect has been is that I’ve probably estimated that it would move faster on some of that than we have. And as far as getting revenue out of those countries in 2017, part of that is just we’ve been so focused on the FDA answering their questions that when you’re a small shop you can only do so many things.
So our focus has been really laser focused on the DFU trial in the U.S. for FDA approval. We could probably add another five or six countries in the next month. But to get them then to revenue takes a while and so which I don’t want to say we pull back on it but we want to make sure that when we announce a country, we announce an initiative into a country that we have the ability to get it registered quickly, get the KOLs engaged and then six months later really start a hard launch of that product. So I think that’s where some of the disconnect is occurred.
And the other piece here is that, we had anticipated Brazil – revenue in the third quarter from an accounting standpoint, it falls into the fourth quarter and that’s just the timing of the payments. And so I think that’s part of where you’re seeing some of the disconnect as well so that will fall – the payments from Brazil will fall in the fourth quarter.
And then I would say the only other thing that from a disconnect standpoint, we had expected South Korea to come back a little stronger this year. And it hasn’t been as strong although meeting with them last week, their pipeline is really strong and we monitor how much the activity they’re engaged in because we do software on the reimbursement. So we know how many patients they are treating, they’ve gone through close to 400 reimbursement cycles or – somewhere between 300 and 400 reimbursement cycles. And so we know there’s a lot of activity and that’s starting to pick up again for them. I think some of the KOL work that André and Pete alluded to that they’re doing on scar treatment and DFU will help them as they entered into next year.
And again their initial order book for next year is dramatically larger than we’ve ever had out of any one country. So right now I would say those are the reasons for the disconnect would be probably over optimism on the ability to ramp once we sign a country through registration, through KOL and then placing orders; two, the timing of Brazil; and then three, South Korea being a little behind what we had dissipated this year. So that’s I think the reasons the sales haven’t matched necessarily what we have expected.
At the end of the day, I mean, I’m hoping that when we look back a year from now, after FDA, after we’ve rolled out in the U.S., after we’ve rolled out in more of these countries, you get Brazil up and running, you get some of these other joint ventures up and running. We’ll look back and quite frankly call these rounding errors because the market opportunity we’re talking about is hundreds of millions, billions of dollars, and we’re just kind of starting this engine going this year, especially on the wound side and that takes these clinical – this clinical work to kind of support that and that’s really what we’re trying to build towards so that in 2018, 2019, 2020 where you’re seeing rapid growth.
So I don’t want to say we’re not as focused on what happens in the quarter, but it’s really laying the foundation forward so that we’re having quite frankly I am looking forward to the call when I can say we couldn’t meet our demand in the quarter because we had so many orders. And I think that’s where we’re headed early in 2018 especially with an FDA approval. I don’t know if that helps, but that’s what’s happened in 2017.
Brian Marckx
Yes, it does, I appreciate all the detail. Kevin, how many of the distributors that you’ve signed during 2017 I think you said, I can’t remember, either six or seven I believe. How many of those are waiting on regulatory approval in the respective countries if any?
Kevin Richardson
Yes, sure. Yes, so if you go down that six – probably five are waiting. So Brazil is one. Indonesia is two. Romania is three. Canada is four. André help me here. Of the six, I think five are – only one has gotten through regulatory – André help on that one.
André Mouton
There has – we do have a device license in Canada. That’s one there.
Kevin Richardson
Okay.
André Mouton
But all the others are in process, one way or another for approval. I think the pretty much six months to eight months process, and they’re all – and actually some one or two countries are much longer. But they’re all in process right now. Some in Taiwan, its – I think we closed to the end on that one. That’s probably going to be the first one will be able to face approved hopefully early next year.
Kevin Richardson
Yes.
Brian Marckx
And maybe you can kind of help on what the process is with – when you a sign a new distributor? What is the new distributor do? Clearly KOLs addressing are – focusing on KOLs is typically a strategy that a lot of distributors will follow. But on top that, will they looked actually runs a investigator initiated studies? Will they do any kind of clinical work to support kind of the marketing effort in their individual countries?
Kevin Richardson
So to start, each country is different, but I would say that, when we sign a new country, their first thing is getting registered and that’s a whole process that we’re refining and getting it down.
And once we have, quite frankly, FDA it becomes a lot easier. Even though, the client CE markets good enough and so forth. FDA is a goal standard out there. So once we have FDA that process tends to speed up. Their job is to really focus on, what is their market opportunity and how do they address it. Live learn from launch in another countries, you need – it’s really important to get one or two KOLs involved to get them to do what we call case work which is not full clinical trial. Clinical trials take a long time cost a lot of money, case work is what they’ll do enroll somewhere between 4 and 10 patients and basically do testimonials.
And that’s really what they look to do. And that takes three to six months, just three months or 12 weeks, if we’re closing and move in 12 weeks, that’s really good. So it takes three to six months. And that’s when they can kind of then go to a broader market and work on selling the wound product on a broader basis. So I think getting these signed up, getting them in not process getting them product registered having the KOLs initiate case work. Really is – it’s kind of three step approach and then quite frankly, it opens a market up. And I think that’s kind of the process that we go to country by country.
Brian Marckx
Okay. And Kevin not to focus to too much on sort of the immediate term, but just kind of for my modeling purposes that would help. I think on the Q2 call, I expected – I think it’s fair to say that you expected Q3 would be a stronger than it is and you – my first question. But also I think I think you mentioned that 2017, you expected that to be up from 2016, so just again for kind of my modeling purpose, still something that you think is doable.
Kevin Richardson
I would say, it’s stretch at this point and it comes down to timing of the FDA, when I think that that’s really where it comes down to I think so, we were looking at South Korea coming in for kind of half what they did last year. And right now, I think the timing is going to shift more to January on that. So as far as, Q4 goes, the flop of the – meaning of flip flop from Q3 to Q4 on the Brazil recognition will help Q4 numbers, but at the end of the day, that’s not going to be enough to push it over the edge. So that we’re up on the year, I think it’ll come down to some of these orders.
And quite frankly, it will – at the symposium, we’re going to be kind of hammered everyone to see where they’re not for end of this year and into next year. I mean, physically, I don’t think it will – at this point, where we are. I don’t think physically, we could actually top 2016 from an inventory standpoint for us to actually do that would – I call it impossible unless we get some other licensing deals are signed some of these other joint ventures or exclusivities before year end, which are possible. But I don’t – those are kind of one-offs, so I don’t want to bank on those just from an order book standpoint though – based on where people have informed us for planning purposes for 2018, I’m really excited about 2018 and maybe, we can pull some of that into 2017.
Brian Marckx
Welcome. One more and it relates to MundiMed in Brazil. Do you know, what the classification of NeuroPhase will be there? Again, over to be Class II, and it’s going to be either Class II or Class III. And then the other part of that question is, what are your expectations in terms of the clinical study or studies that will need to be completed to support the regulatory approval there – is your expectation it’ll be randomized control study or is it maybe not so, so robust?
Kevin Richardson
I’ll answer the second question first. And then I’m going to punted over to Pete to fill in the blanks when I missed that. There is no – we don’t need to do any more clinical work in Brazil. The work we’ve done in the U.S. with our 336 patient double-blinded study will be the documentation used for ANVISA approval. That becomes easier with an FDA approval through the ANVISA process. And so it will speed things up there. We don’t have to enroll anyone. The work we’re going to be doing in Brazil is really to help support the marketing efforts. And that’s what I alluded to getting KOLs engaged on a country-by-country basis.
That’s the type of work we’ll be doing in Brazil. It’ll be more – my guess is they’re going to do some vascularization work given the KOLs we’re engaging. Ones well known plastic surgeons, so I could envision him doing some work on Scar items. But I think that’s more on the marketing side in supporting that from a from a case study standpoint. I don’t – there’s nothing clinically that they need to do, we have everything that they have. That they need to get in a ANVISA approval already done. And so it’s just a matter of going through the process Pete you want to fill in the blanks for that neglected to mention.
Pete Stegagno
Pretty much there it’s a Class II devices. And so it will go through the ANVISA which is Brazil’s FDA, because it’s an electronic device, it also will go through a mechanical – excuse me a mechanical electrical review by organization cause in Metro, it’s a state testing facility primarily. So I mean, yes, that’s primarily process. The same process we went through in Korea pretty much the same process for Taiwan, so it’s nothing new and it’s just repetition country by country.
Brian Marckx
Okay, great. Thanks guys. Appreciate it.
Pete Stegagno
Thanks Brian.
Operator
Thank you. [Operator Instructions] Okay. There appear to me no questions at this time. I will now turn the floor back over to Kevin Richardson.
Kevin Richardson
Great. Thank you everyone for joining the call. Thank you for the update. I’m hoping that we’re going to be back on a call before we announce Q4 results, talking about FDA or talking about another country that we’ve entered from a joint venture standpoint. Hopefully that will happen soon, and we’ll be chatting again. In the meantime, if anyone has any questions, please feel free to reach out to us and we will answer as best we can. Thank you.
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