Axonics Inc

NASDAQ:AXNX

Earnings Call Transcript 2018-Q3

[Operator]

Good day, ladies and gentlemen, and welcome to the Axonics Third Quarter 2018 Results Conference Call. At this time all participants are in a listen only mode. [Operator Instructions] Later, we will conduct a question-and-answer session and instructions will follow at that time. As a reminder, today's conference may be recorded.

I'd now like to introduce your host for today's conference, Mr. Matt Clawson, with W2O Group. Sir, please go ahead.

[Matt Clawson, W2O Group, IR]

Thank you, Liz. And thanks everyone for joining the first Axonics quarterly results and update call, following the initial public offering completed in early November. Joining me on the call from Axonics this afternoon, are Ray Cohen, Chief Executive Officer; and Dan Dearen, President and Chief Financial Officer. Ray and Dan will provide prepared remarks and commentary on the progress in recent weeks and months, followed by a Q&A session.

Before we begin, I'd like to remind listeners that statements made in this conference call that relate to future plans, events, prospects or performance are forward-looking statements as defined under Private Securities Litigation Reform Act of 1995. While, these forward-looking statements are based on management's current expectations and beliefs, these statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause results to differ materially from the expectations expressed in the conference call including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov.

Listeners are cautioned not only to place undue reliance on these forward-looking statements which speak only as of today's date December 11, 2018, except as required by law Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, circumstances, unanticipated events that may arise.

With that said, I'd like to now turn the call over to Ray Cohen for his remarks. Ray, good afternoon.

[Raymond Cohen, CEO]

Thanks, Matt. And thank you to everyone who's dialing in for today's call. So we're going to start off with Dan Dearen, our President and CFO, who will kick off the call by reviewing our Q3 2018 numbers and then I'll provide an update on operational initiatives and items that we're keenly focused on in the months to come.

But before we do that, I'd like to start by thanking all of our new shareholders for supporting our recently concluded IPO where we raised $138 million and netted $126 million after deducting for underwriting costs and offering expenses. The capital is allowing us to move forward with velocity towards accomplishing our primary objectives, which is to build inventory to support international sales in 2019 and to have sufficient product on hand to launch our product in the United States.

In addition, we are executing on initiatives with respect to regulatory filings, marketing, quality assurance, sustaining engineering, product development and expanding our sales efforts in the UK and of course recruiting, hiring and training of our U.S. field sales and clinical personnel.

And in addition, as everyone would expect, we're working diligently to complete the 129 patient ARTISAN-SNM pivotal clinical study for patients with urinary urge incontinence.

So Dan, I'll pass the call to you.

[Dan Dearen, President and CFO]

Thank you, Ray. For the quarter ending September 30, 2018, we reported net revenue of $201,000, which is an increase of $73,000 from the third quarter of 2017. Net revenue for the third quarter of 2018 was derived from the sale of our r-SNM Systems to customers in Europe and Canada. Net revenue for the same period in 2017 consisted of a sale to a single customer in Canada.

The gross profit for the third quarter of 2018 was $95,000, an increase from $10,000 in the same period in 2017. The lower gross profit in the third quarter of 2017 is due to a one-time evaluation agreement with a hospital in Canada.

Total operating expenses for the third quarter of 2018 were $7.6 million, which is an increase of $3 million compared to the same period in 2017. The increase in operating expense was driven primarily by increases in legal and consulting costs associated with the preparation for our initial public offering, growth in personnel, and clinical development and study costs associated with the demonstration of the safety and effectiveness of our r-SNM System and to support regulatory submissions.

Operating losses for the third quarter of 2018 were $7.5 million as compared to operating losses of $4.6 million in the third quarter of 2017. Cash, cash equivalents and short-term investments on the balance sheet were approximately $31.2 million as of September 30, 2018. In November of this year, as you know, we closed our initial public offering raising total gross proceeds of $138 million before underwriting discounts, commissions and offering expenses.

The cash, cash equivalents and short-term investment balance at November 30, 2018, was $159 million.

And now, I'll turn the call back over to Ray.

[Raymond Cohen, CEO]

Great, thanks, Dan. So as outlined in our news release we're continuing to make really good progress on the international launch of our long lived rechargeable SNM System. In late November, we announced that our system got listed on the UK’s National Health Service Supply Chain online catalogue. And this is important because given most UK hospitals no longer have their own purchasing departments there's virtually no way to do business in the UK any longer unless a hospital can order from the NHS catalogue.

We currently have three sales professionals and one clinical specialist in the UK, who are actively securing orders and doing implants. Yesterday we announced that the UK’s National Institute for Health and Care Excellence better known as NICE published a med tech innovation briefing on our SNM System. It's the first step in a process with NICE. We'll continue to work with these folks and provide more clinical evidence with the objective of an unqualified recommendation of our product versus the incumbent.

The UK is the fairly modest size market, there's only about 800 to 1,000 de novo implants per year. We are currently opening new accounts and securing both initial and repeat orders for commercial implants in the UK. The reaction to our products has been excellent and the NICE briefing should further aid us in gaining traction in the UK.

So I believe that we're well-positioned to compete in that market and generate measurable revenue in 2019. We continue to stay disciplined in our efforts outside the U.S. so as not to lose focus on the bigger prize, which clearly is the U.S. market.

Regarding our regulatory initiatives in the United States, as we have announced and stated many times gaining FDA approval is the single most important objective for Axonics and as such we are aggressively pursuing the literature-based PMA path and also continuing to gather clinical data using our IDE study in order to obtain U.S. marketing approval in the shortest possible timeframe.

On December 3rd, we submitted a literature-based PMA to the FDA. PMAs take typically 180 days split into two 90 day review periods and that doesn't include delays for responding to questions after reviewing comments for the first period. As stated in our release of last week, that implies the earliest approval date that we would expect the summer of 2019.

On December 7th, the FDA approved an IDE supplement regarding our ARTISAN-SNM pivotal clinical study of the Axonics r-SNM System. The ARTISAN-SNM clinical study is intended to serve as the primary clinical support for the company's traditional PMA filing. The supplement proposed among other things changing the primary endpoint to an intent to treat analysis on all implanted subjects.

In addition, the FDA provided certain feedback with respect to the submission of analysis of a partial cohort of subjects that have reached their six month post implant time point. We continue to have good relations with the FDA and we are in a constant dialogue with them with respect to the conduct of the study. We have an excellent relationship with the FDA and we will continue to do everything we can to move the ball forward in that respect.

So we're keenly focused at the moment on concluding our ARTISAN-SNM pivotal study, our clinical team is hard at work on completing the remaining six month follow ups on the last dozen or so patients that we have. We expect all subjects to reach their six month post-implant endpoint certainly no later than early January 2019. The clinical results continue to be outstanding and in fact today marks the one year anniversary of the start of our ARTISAN-SNM study and we actually have five patients who have already reached the 12 month time point in our study.

So the key takeaways with respect to this section of the discussion are that we have two shots on goal with FDA and we're going to continue to be aggressive in pursuing both paths.

So moving on to the next major topic which would be regarding our activities relating to hiring sales professionals in the United States with respect to our U.S. launch. So we're also focused on securing the most talented salespeople and sales field professionals that we can. Our first step in this process was to hire a group of very experienced and talented sales managers. As of today we have nine of those sales managers employed by the company.

In addition, we have over 20 sales folks who signed on with the company and will effectively be starting employment with Axonics on January 15, 2019. So, so far the talent has been literally off the charts. We've been very fortunate to be more in a selection process than a recruiting process.

Folks are coming to us from the spinal cord stimulation space, these are people who have experience in neuromodulation. Some of which you may have even sold InterStim for Medtronic in the past and others who have worked for or were currently working for urology focused companies.

The sales people out there, they understand the opportunity at Axonics and they're actively seeking us out. So we're in an enviable position of drafting only A plus players or using a sports analogy these are our first round draft choices and we're real pleased with where we are.

Just to answer maybe a question before it’s even asked, we're not hiring any current Medtronic salespeople and we don't intend to. So further to that, we're going to ensure that we have the best trained team in the industry. We have the time and we have the resources to make that happen. So we're going to use the next six months or so, or however long it takes to get FDA clearance to make sure that our people are well trained and are prepared to go out there and compete to have us fulfill our vision of being the market leader in Sacral Neuromodulation.

Couple of other comments with respect to this topic, we're going to be really vigilant to ensure that none of our sales people are promoting the product ahead of FDA approval. We understand the risks associated with that and we're going to be very vigilant in that regard.

So our goal is to have between 60 and 100 field sales people along with 10 sales managers and a few dozen clinical specialist hired and trained prior to summer or by the summer of 2019. So overall, we're making excellent progress on our operational and clinical initiative and we're happy to at this time answer any questions that folks may have.

[Operator]

[Operator Instructions] Our first question comes from the line of David Lewis with Morgan Stanley. Your line is now open.

[David Lewis, Morgan Stanley]

Good afternoon. Ray, a couple of regulatory questions if I could. One, I just wondered if you can update us on the IDE change and intent to treat sort of walk us through that process and any implications? And also just broadly, if you could sort of characterize the process with the agency now, obviously you intend to pursue a literature based PMA. Are you still committed to submitting a traditional PMA?

And I wonder, if you could also just share with us any response from the agency around the six month data, and does that inform your view as to whether a six month endpoint is sufficient. So I think three kind of related regulatory questions there, and maybe a quick follow-up.

[Raymond Cohen, CEO]

Okay. I'll try to take in the order that they were asked. So first of all, the modification in our amendment to change the primary endpoint from a proportion of test responders to the intent to treat or all implanted subjects. As you may recall, David and others who read our perspective that this was one of the observations or design considerations that the FDA had made appended to the back of the IDE.

So in effect, this is really nothing more than our continuing effort to come really in alignment with what the FDA would like to see from us. We had always intended to provide an intent to treat analysis, but we had it as our secondary endpoint and we had the proportion of test responders as the primary endpoint, now we've switched them. The study was powered for both endpoints to begin with. So really, there's no real difference and anything with respect to the conduct of the study, or quite frankly, even in the analysis of the study. I think, this is just a cleaner approach with respect to ultimately submitting this clinical data in the way that they would prefer. So that's the first comment.

With respect to the traditional IDE filing or traditional PMA filing, I think that our position there is simply that we have that option and that we will continue to engage in dialogue with the agency and then make a decision when the time comes. As you know, we have intended and said all along that we would wait to file a traditional PMA until all subjects had reached their six months endpoint and then we would quickly do the analysis, we're fully prepared to do that.

As you know, we've already analyzed the interim data. So we have the methodology and everything that we need. And then, we'll make a decision whether it makes sense for us to do that or not. The earliest date that we would look to file a traditional PMA would be in the February timeframe.

The third question you asked was, did we learn anything from FDA with respect to the submission of our supplement with respect to the partial cohort or analysis of the partial cohort of patients at six months? And the answer there is that the feedback that we got from the agency was with respect to some of the details associated with how to analyze that data and in what format they'd like to see that data. It's fair to say that the company will be submitting interim data to the FDA. And that was part of the reason for the supplement to make sure that what we do filed with them is in a format that they would like to see it in.

So, I don't think these changes our view in terms of maintaining optionality and having two shots on goal. I think, anytime that you have communications with the FDA, of course, as you know, verbal communications are not binding, written communications are. So it's always best to get these things on the record. And we've done that successfully and I think we continue to demonstrate that the company is in close contact with the agency and this is a very collaborative approach and we feel really good about where we are.

Look the facts are the agency gave us permission to do an interim analysis. As you know we did it for three month data, which was then published in the S1 and we also indicated at that time we would like to do an interim analysis on a partial cohort of six month data. So where everything is coming together exactly the way that we would have hoped it would. And I think we're in great shape and more importantly the data that we have -- the quality of the data that we have is quite positive. And ultimately that's what's going to win the day for us, whether that’s relative to FDA approval or ultimately in the market.

[David Lewis, Morgan Stanley]

Okay, very helpful, Ray. Just a quick follow-up for me and I'll jump back in queue, just on the commercial progress here the 30 reps. Is it safe to assume now we are focused on a 60 rep number now you're saying sort of 60 to 100 so based on this traction you've made to-date is it safe to assume that you see 60 reps at the time of launch is now kind of a base case estimation. Thanks so much.

[Raymond Cohen, CEO]

Thanks, David. I would say that's a very fair comment.

[Operator]

Our next question comes from Larry Biegelsen with Wells Fargo. Your line is now open.

[Larry Biegelsen, Wells Fargo]

Hey. Good afternoon, guys. Thanks for taking the question. Let me start with a couple of follow-ups on the regulatory side. Ray, the press release talks about the supplement proposed among other things. So my first question is what other proposed changes did you make and did the FDA accept them?

And I'll just tack on my second regulatory question here, can you confirm that the performance goal you still have to meet is a 65% -- I think 65% responder rate at six months and this compares to I think the 87% or 88% responder rate at three months in the S1. I realize the performance goal you have to meet is at six months and the data we saw in the S1 is three months. And I had a follow up question.

[Raymond Cohen, CEO]

Thanks Larry. Trying to figure out exactly the details of the question.

[Larry Biegelsen, Wells Fargo]

What were the other proposed changes you made in general, I'm just curious just among other things.

[Raymond Cohen, CEO]

Sure, I would say that they're not meaningful and certainly they're kind of inside baseball stuff regarding statistics and things of that nature. So I don't think there's much value in going down that path. Certainly nothing that that is really meaningful to the big picture here.

The second part of the question...

[Larry Biegelsen, Wells Fargo]

Yes, the performance goal, I think, the performance…

[Raymond Cohen, CEO]

The performance goal has not -- the goal posts have not shifted. I mean, the statistical analysis plan that was submitted, the IDE that was approved all these things are historical at this point. We're talking about what was agreed with the FDA back more than a year ago and nothing has changed, performance goal hasn't shifted and we've always talked about an intent to treat analysis. We've always talked about results for all implanted subjects.

If you look at the proportion of test responders, the numbers are simply better than all implanted subjects, so we are like double winner there. So no issues with any of that. And was there a five part that I missed.

[Larry Biegelsen, Wells Fargo]

No, no. Is the performance goal 65% is that the right number at six months. Is that what you need to do in all responders?

[Raymond Cohen, CEO]

Yes, I think that's substantially correct. Maybe it's 63.5%, but substantially, that's correct.

[Larry Biegelsen, Wells Fargo]

Okay. All right. And then a couple of commercial questions, maybe competitive questions where it give you an opportunity, obviously we're hearing from the competition a lot. So I wanted to give you an opportunity to talk about that. So first, on Medtronic, any response you've seen so far.

I know it's early, if you've seen any competitive response. And just second, I think people are pretty familiar with InterStim, but maybe it would be helpful if you could compare and contrast your technology to new vectors, which looks like they might be a little bit ahead of you in the U.S. if the pay per PMA is accepted. So I just want to give you an opportunity to talk about both of those. Thanks for taking the questions, guys.

[Raymond Cohen, CEO]

Sure, Larry. So first of all, I have really nothing to say about Medtronic. I don't know what they're doing. We have no information. We've seen -- we really haven't seen or heard much of a response from them. I'd leave it for you to question Medtronic if they care to speak about this business. We're not -- as you know we're not in the market. No we're not trafficking with healthcare providers in the United States because we don't have approval. So it wouldn't be appropriate for us to do that. So, I think, I can't really say much there.

With respect to your comments on the other company, once again, that that's I'm not running that business, so I really can't say much about it. I think, we've been pretty well on the record that we've created a product which we think based upon feedback from the physician community in the United States and around the world is and this is their words the perfect product for Sacral Neuromodulation. I can tell you that my product is not suitable for spinal cord stimulation, but it's the perfect product for Sacral Neuromodulation and why?

Well, first of all it's the smallest neuro stimulator implant ever made by any company in the world. We have a 5cc device. As you know the incumbent has a 14cc non-rechargeable device, ours is obviously rechargeable. Others who are interested in entering the market, we understand that that device is around 20cc.

So that's four times the size of our product. And size matters particularly in this market and particularly for this patient population. There is not a spinal cord stimulator business. We're not talking about large men, we're talking about females who are the predominant patients that we're dealing with.

Our device has been qualified and validated by virtually every regulatory agency around the world that matters for a 15 year minimum life in the body. And there's no reason why it can't last longer depending upon how it's programmed and so on so forth. So we think that is a huge advantage and if anybody took the time to read the report from NICE, you can see that they think this is a really important feature of our product and can lead to significant cost savings not only in the UK, but anywhere in the world.

Our recharging interval is the best in the business irrespective of what product or what neuromodulation product you might have. Our current interval is recharging the product once every two weeks for one hour. That's a phenomenal interval and it will only get better.

I think everybody knows we've got a beautiful, small, easy to use, wireless patient remote that doesn't require an engineering degree to be able to use. We have a clinician programmer, which is circuit 2016-2017 technology, touch screen, intuitive, makes recommendations based upon the intraoperative responses and then translates those into how the products should be programmed. So this is -- there's some pretty cool features in that.

Our product is currently MRI compatible for 1.5 and 3T. And our device absolutely is full body MRI-compatible, it was designed to be that and we have the testing data that shows that that is the case. And as we've stated, certainly in the S1 in our road show, we fully expect to have a full body MRI approval shortly from our notified body BSI in Europe.

And then the last and probably the single most important feature of our product as it compares to the current product that's being sold is the constant current stimulation where our device has the ability to adjust based upon the resistance to current or the impedance that it sees, and we think that has fundamentally mitigated the fuss factor associated with this technology. So when you stack up all these features and benefits, we think we're going to be pretty hard to beat.

And any comments about things that there's no clinical evidence to support like bilateral stimulation, which there's no clinical evidence that suggests, in fact there is clinical evidence that suggests it's not important. So, people can make up whatever kind of story they want. The difference is that we've been focused only on this business, only on this technology since we started this company five years ago, financed it originally in March of 2014.

So, this is our business, our vision is to be the market leader in Sacral Neuromodulation. We have a purpose built device specifically for this clinical application. So sorry if I was a little wordy, but that's just to reinforce it that's the story.

[Larry Biegelsen, Wells Fargo]

Perfect. Very comprehensive. Thanks for taking the questions, guys.

[Raymond Cohen, CEO]

Thank you, Larry.

[Operator]

[Operator Instructions] Our next question comes from line of Bruce Nudell with SunTrust. Your line is now open.

[Bruce Nudell, SunTrust]

Good afternoon, guys. I have three questions, one Ray, RELAX-OAB was fully comparable to the InterStim to results in a tough population, ARTISAN had a 88% responsiveness and it looks like it's going to have 90% stability. So you're really talking almost 80% survival of responsiveness on an intention to treat. I mean, what possible reason would the -- and given the engineering advances, what possible reason could the -- might the FDA balk at this literature-based PMA?

[Raymond Cohen, CEO]

Well, I think, we're in a way conflating clinical results with the literature-based pathway, right? As everybody -- well, I think, this whole topic of literature based PMA. We all understand, this is not a well-worn path and it's been somewhat confusing I think to everyone not only the manufacturers involved, but also to analyst and to investors. But in theory, the literature-based PMA should not have to take into account clinical data. And so, you're really talking about the safety of the product, making sure that it -- you have all the right test data to support whether it's anything from EMC bio compatibility, et cetera, et cetera.

So I think -- and then the comparison to the already approved PMA product. So, you need to have an equivalency argument there. So, that means you need all the various different tools, whether it would be everything from an external trial to similar stimulation parameters, et cetera. So, that's the case there. As you can see, and I think it's obvious to people who are following the company that we have a lot of clinical data. I mean, certainly, a lot as compared to even what we've seen in the spinal cord stimulator business.

So with 51 patients in a controlled study in Europe, and then 129 patients in this study plus you combine that with the case series that we've done, et cetera, et cetera. We have a good size of clinical evidence that continues to mountain as patients accrue longer and longer having been implanted, it's clear that this is a stable therapy, and that patients continue to do really well, even overtime with our product.

So what we're looking to do is we have this clinical data, the agency knows perfectly well, they gave us approval to do the study, they gave us approval to look at three months data, they gave us approval to look at six month data. And the fact is, why would we keep that a secret from the agency, right? It would not be logical. So we're going to make sure that they get the full benefit of all the work that we've done from a clinical standpoint and I would hope that they will take this into account. And look favorably upon us.

We've got a solid product and from a safety standpoint we've not had one serious device related adverse event since we started in any of our controlled studies. So we've got a perfect safety record, we've got a highly efficacious therapy and we've got a solid product and we've got all the test data to support any claim that we've made. So, Bruce, I really appreciate the question in a way it's kind of a layup for me. I mean, I cannot come up with one reason why this product will not be approved.

Having said that, the FDA has time clocks and they have a process. And they have to go through their process. And so, I wish we could speed it up and move faster as you can imagine, we're anxious to get to the market, but we just need to be a little patient at this point and continue to be disciplined and follow the path that we've set forth. We could have taken lots of shortcuts in this company, we've not taken one. And, I think, that that's something hopefully that our shareholders appreciate as we go forward.

[Bruce Nudell, SunTrust]

And basically, I'll just combine other two questions. One, some investors have voiced concern that the literary literature-based PMA pathway will lower the bar for major potential competitors like Boston [ph] and Abbott. What's you’re feeling about that just in terms of the amount of time it takes to make a competitive product? And secondly, in the due diligence full body MRI was clearly an important concern for doctors -- for patients. They don't want to have to explain the device that somebody certainly needs a full body MRI. And also they're reluctant to implant the device to the first place for a patient who may need a full body MRI in the future somebody for instance with back pain. Just, what's the status of Europe and what would -- what does that mean -- what does the favorable outcome there mean for the data that you amassed and the likely approval in the U.S.?

[Raymond Cohen, CEO]

Sure. Thank you, Bruce. I appreciate that question, that's an important question -- two important questions. So one, our product is full body MRI compatible. That's a fact from a technical standpoint. We've gone through all of the phases necessary with our notified body in Europe and those certificates are pending. Unfortunately they are horribly delayed in Europe and I'm sure this is a theme you're going to hear from many companies and executives from lots of companies that you follow. The timeframes have just disintegrated in terms of anything that people used to be able to expect. They're really backed up.

And this has no reflection on Axonics, this is just the way that it's happening, I mean, the time the timeframes have just been expanded dramatically. So that's unfortunate. It's unfortunate for everybody in our industry and it's unfortunate for our patients, but we expect to have that upgraded certificate and to be able to have that claim of full body MRI for the CE mark in Europe in short order.

Okay. So then when I move to the U.S. We have filed technical data with the FDA with respect to MRI compatibility and labeling for head and neck for 1.5 and 3T devices. The agency has seen that data, it was part of our literature-based PMA filing. It was part of our first filing. So they had maybe one question with respect to that we've got zero concerns about where we sit in that respect.

I will tell you that we are in communication with the agency that we have a very good sense about what is required to be able to get full body MRI labeling on our product with U.S. approval. And we are endeavoring what I'll say is this, we are endeavoring to get that approval upon launch. Now we may be off. It may take a little more time if there are some Ts to cross or Is to dot. But it's -- the product was designed to begin with we've never made one change in one circuit from day one and we've passed every test that there is with respect to MRI full body compatibility.

So we're supremely confident. It's just a question of time and the regulatory process associated with that. So that I took questions in reverse.

With respect to the literature-based PMA, Axonics did not invent this process. We are we are not the creators of the literature-based process. I mean, this is the -- FDA created this process. For us as a company not to avail ourselves to have this shot on goal. Then I would think that shareholders would be asking me, Ray, why aren't you doing this. So, if we boycott this, how does that help anybody, how does that help the company. It doesn't make any sense, right? So we we're obliged to do it. And it's not something we've created, it's a pathway that's available to us and that we're going to go ahead and do everything we can to get to the markets in the shorts.

Would I have preferred that the FDA didn't have this pathway and that everybody would need to do clinical work in order to get approval, absolutely. Because I think that's the right thing to do irrespective of what the regulatory pathway might be. It is important comment that I made, that we believe clinical data is important and it's certainly critical when it comes to marketing your product. I mean, this is -- we're dealing with urologists and urogynecologists, these are conservative physicians. They feel that this data is important and I daresay that you're not going to get anywhere in this marketplace unless you have clinical data.

Now, with respect to kind of part of your question, it's this notion of how could somebody else get to the market. I want to start by saying, we invite all the large players in neuromodulation to enter the Sacral Neuromodulation market, come on down, I mean really.

The more players we have in this market, the more the market will grow and the rising tide floats all boats and there's no reason why Sacral Neuromodulation shouldn't be a $2.5 billion business because certainly there's millions and millions -- tens of millions of patients who could be benefited by this technology.

In terms of timeframe, I mean, look we were focused on one thing, one thing as a company and a team that’s been -- engineering team has been working together for almost 20 years. We spent tens of millions of dollars over more than four years to develop this purpose built product. Now, I think that anybody who wants to repurpose their spinal cord stimulators if they want to be able to have a product, which is going to be competitive with what we have then it's going to take them some years and it's going to take them millions of dollars, that's just the fact.

And then, they're going to have to navigate the regulatory pathway and the literature based pathway is no walk in the park. This should be clear to people, I mean, this is a process that is rigorous and it is not a lay down. I mean -- and I think that the facts are on the table here that this is not like, oh you throw some stuff over the wall and 180 days later you get your green card to go sell in the U.S. that has not been our experience, that's not been the experience of the other player in the market who has attempted to do this.

So, I think, that it doesn't really lower the bar quite frankly. And if you're getting questions from shareholders or other investors about this lowering the bar, I think that they probably haven't done enough work to understand the magnitude of what really needs to be done to be able to get approval. So enough said there and I really do appreciate the question, Bruce, it's a very thoughtful question.

[Bruce Nudell, SunTrust]

Thanks so much, Ray. Take care.

[Raymond Cohen, CEO]

Okay, thank you.

[Operator]

And I'm not showing any further questions in queue at this time. I'd like to turn the call back to management for closing remarks.

[Raymond Cohen, CEO]

Super, thank you. Look, I really appreciate the questions from David and Larry and Bruce that was been helpful to be able to articulate a couple more themes. We appreciate everybody's interest in Axonics. We look forward to seeing you at JPM in San Francisco in early January. And we wish everybody all the best for the holidays. Thank you so much for listening in today.

[Operator]

Ladies and gentlemen thank you for your participation in today's conference. This concludes the program and you may now disconnect. Everyone, have a great day.