VANI - NASDAQ

Ladies and gentlemen, thank you for standing by and welcome to the Second Sight First Quarter 2018 Results Call. During the presentation, all participants will be in a listen-only mode and afterwards we'll conduct a question-and-answer session. [Operator Instructions] As a reminder, the conference is being recorded Thursday, May 10, 2018. And now I'd like to turn the conference over to Lisa Wilson, Investor Relations for Second Sight. Please go ahead.

Thank you. Good afternoon and welcome to Second Sight's first quarter 2018 earnings call. This is Lisa Wilson of In-Site Communications' Investor Relations for Second Sight. With me on today's call are Will McGuire, President and Chief Executive Officer and John Blake, Chief Financial Officer of Second Sight. At the close of market, the company issued a press release detailing financial results for the three months ended March 31, 2017. The press release can be accessed through the Investor Relations section of the Second Sight website at secondsight.com. You can also access the webcast of this call from there. Before we get started, I would like to remind everyone that any statements made on today's conference call that express a belief, expectation, projection, forecast, anticipation, or intent regarding future events and the company's future performance may be considered forward-looking statements as defined by the Private Securities Litigation Reform Act. These forward-looking statements are based on information available to Second Sight management as of today and involve risks and uncertainties, including those noted in this afternoon's press release and Second Sight's filings with the SEC. Such forward-looking statements are not guarantees of future performance. Actual results may differ materially from those projected in the forward-looking statements. Second Sight specifically disclaims any intent or obligation to update these forward-looking statements except as required by law. A telephone replay of the call will be available shortly after completion of this call for the next two weeks. You'll find the dial-in information in today's press release. The archived webcast will be available for one month on the company's website, secondsight.com. For the benefit of those who may be listening to the replay or archived webcast, this call was held and recorded on May 10, 2018. Since then, Second Sight may have made announcements related to the topics discussed. So, please reference the company's most recent press releases and SEC filings. And with that, I'll turn the call over to Second Sight's CEO, Will McGuire.

Thank you Lisa, and thank you all for joining our call this afternoon. With several key developments during and since the first quarter, I believe Second Sight is better positioned than ever before to treat the blind by expanding the reach of our Argus solution and advancing our Orion technology. I'd first like to review key changes to our management team and board of directors. Let me begin by welcoming John Blake to his first call as Second Sight CFO. John is a seasoned financial executive with broad life sciences industry experience and a track record of delivering results. I am pleased that he has joined Second Sight's leadership team and that I will be working with him once again. I'd also like to take a moment to thank Tom Miller for his many contributions to the company. Tom was a valued member of the management team and integral to the company's successful IPO. He graciously helped ensure a seamless transition to John and we wish him well. As you know, in April, we announced the resignation of Dr. Robert Greenberg from our Board of Directors and as an officer of the company. Bob is a pioneer in the industry and as contributed extensively to expanding options for the blind. I enjoyed working with Bob to advance Second Sight's breakthrough technologies and bring them to market worldwide. Second Sight has benefited from his clinical insights and extensive industry and technical knowledge. On behalf of the entire leadership team, we sincerely appreciate his contributions over the years and wish him well. Also, as previously announced in March, Gregg Williams was appointed Chairman of the Board. As a board member, he has provided valuable guidance to the leadership team and we appreciate his continued confidence in the strategy and future of our business as demonstrated by his $2 million investment last week. Gregg's investment provide Second Sight with funding to achieve key commercial and development milestones this year, including completing enrollment of the Orion feasibility study and continuing to gather clinical data to support safety and efficacy of this breakthrough technology, further implementation of our Centers of Excellence strategy to drive adoption of the Argus II, completing development of our next-generation Argus II externals and seeking regulatory approvals, and pursuing regulatory approvals to treat better vision patients in order to expand the treatable population for Argus II. So let me now turn to a discussion of our business during and since the first quarter and what we believe will be a significant year ahead. Let's start with a very exciting progress we're making with our Orion. On January 30th of this year, we implemented our first human subject at the Ronald Reagan UCLA Medical Center or UCLA. We have since been successfully activated as part of our feasibility study. As a reminder, we are conducting a five-subject feasibility study at UCLA and the Baylor College of Medicine in Houston. I'm very pleased to report that four of the five Orion study subjects have now been implanted. The fifth surgery has not been scheduled yet but is expected to occur later this quarter. The first two subjects have been activated and the stimulation sessions have gone well. You may recall that the testing is phased with each of the 60 electrodes being stimulated individually during the first phase. The first two subjects have perception or see spots of light from all sixty electrodes. The next phase of testing includes spatial mapping which the process of determining where each electrode produces a spot of light in the subject's visual field. The spatial mapping is underway with the first two subjects and the results appear consistent and the process is progressing as expected. The next phase of testing involves actually turning on a subject's camera. The first subject's camera has been turned on and he can locate light and is practicing head scanning and other visual skills. It's also important to note that there have been no serious adverse events. To be clear, I am quite pleased with our stimulation and spatial mapping results and early testing has exceeded my expectations. Looking forward, we will activate and begin stimulation testing for subjects three and four in the near future. We will also begin testing our first two patients with real-time video input from the camera. The video will be converted by algorithms into signals that stimulate the electrodes in patterns creating artificial vision. I look forward to updating you on our progress during future calls. As part of the breakthrough device program, Orion is eligible for priority review by the FDA. Last week, we completed our initial submission to the FDA and requested a meeting at the next step. Our goal is to advance the discussions with the FDA sufficiently, so that we can update investors later this year regarding the clinical and regulatory path for Orion through to commercialization. Let's now turn to the Argus business. During Q1, we completed ten Argus II implants in North America and have begun Q2 with substantial momentum. Our Centers of Excellence strategy in the U.S. continues to gain traction and we now have a full team in place covering the entire US. Due to our patient outreach efforts, our patient database has grown to over 160 clinician-qualified US patients, up from 125 in early March and 89 at the end of the third quarter. We expect the database to be a growing source of individuals qualified for an Argus implant. In fact, four individuals implanted in North America during the first quarter came from the database and an additional eleven are currently scheduled for surgery later this year. In Canada, the Ontario Ministry of Health and Long-Term Care approved funding for the Argus II based on the previously discussed recommendations of the Ontario Health Technology Advisory Committee. Our center in Toronto is planning to evaluate two patients in the next 30 days, and we expect to implant our first patient under the reimbursement program shortly. With our Centers of Excellence strategy scaling nicely, our growing US patient database and expanded reimbursement in the US and Canada, we expect continued growth in the number of Argus II implants in North America. Turning to Europe, the Middle East, and Asia, we completed six implants during the first quarter of 2018. As discussed in the past, the business in this region is quite complex with many different markets and much more potential for variability than the North American market. With that said, the team is making good progress refining our overall commercial strategy and continuing to secure reimbursement in additional markets. In France, we currently have three sites approved to perform implants as part of the Forfait Innovation Program. As a reminder, the Forfait Innovation Program was launched to accelerate the introduction of promising medical innovation in France but also collecting data to support a longer-term reimbursement decision. We were the first company to be accepted in the program and are planning to submit a final report to the French reimbursement authority by mid-year. After reviewing the supporting data on the first 18 patients, we are optimistic that we will have a positive outcome and ultimately transition to national reimbursement, allowing us to expand the number of centers performing implants in France. We were also accepted in the NHS England's CtE or Commissioning through Evaluation innovation funding program which is similar to the program in France. This program is progressing slower than expected, and we now believe implants under the program will not begin until late 2018 or early 2019. Before discussing R&D, I'd like to highlight the success we've had in our distributor markets since revamping our strategy in late 2016. In the five new markets we've entered since early 2017, we have completed a total of 17 implants, with three markets completing four or more implants each. Overall, we've had great results with some impressive patient outcomes as well. Turning to R&D, we remain focused on improving the Argus technology so that we can not only improve the experience of the current Argus users but also expand our adjustable market to reach better vision RP patients for whom our technology could make a meaningful difference. On that front, we are developing new externals and advanced stimulation programs, design work for our next-generation externals, which include the eyewear, camera, and VPU has been completed and testing is in process. We remain on track to complete regulatory submissions this summer with a launch anticipated in late 2018. Once our next generation externals are ready, we will be able to continue testing various advanced stimulation programs on the newer more capable platform. Again, we are hopeful that these new stimulation programs will improve the quality and/or usefulness of the vision provided to a portion of our patients. We submitted an HDE supplement to the FDA during the first quarter requesting a change to our label in the US that would expand the patient population treatable by Argus II. We are in discussions with the FDA concerning our submission and remain optimistic about our ability to expand the label in the US and we'll update you as appropriate. On a related note, we have made a decision to delay moving forward with our better vision RP trial in Germany given our desire to focus on the substantially larger US market. With that, I would like to now turn the call over to John to review our first quarter financial results. John?

Thank you, Will. I'm pleased to be joining you on my first call as CFO Second Sight and I'm excited to be part of the team. I'm looking forward to meeting with investors and sharing my optimism about our products and our plans to create shareholder value now that I've been able to dive in and get a closer look. Our implant volume during the first quarter of 2018 increased 16 units compared to 14 during the prior quarter. During the quarter, ten implants were performed in North America with the remaining six in Europe, the Middle East, and Asia. Net sales were $1 million in both the first quarter of 2018 and 2017. Revenue was recognized for nine units and four units were deferred this quarter as we apply the new revenue recognition guidance to our new sites without MAC coverage or without prior reimbursement experience. In the same quarter last year, we recognized nine units and deferred two. The average invoice price for implants in the quarter was approximately $109,000 compared to $106,000 for the first quarter of 2017. Gross margin for the quarter was $0.3 million compared to a gross loss of $0.1 million in the first quarter of 2017. We are making progress with our cost reduction efforts on a per unit basis. As a reminder, our unit costs are subject to variability based on our production volumes primarily due to the overhead absorption rate. We expect our cost of goods to stabilize particularly related to overhead absorption and excess inventory reserves as we produce more units. R&D expenses were $2.5 million during the first quarter of 2018 compared to $1.9 million in the prior quarter, largely driven by an increase in personnel outside services and internally produced prototypes for next-generation products. Clinical and regulatory expenses increased during the first quarter of 2018 to $1.3 million compared to $0.6 million in the prior year quarter. This increase reflects an increased enrollment in post-market studies due to the higher level of implants over the last 12 months and expenditures associated with our Orion feasibility study. Selling and marketing expenses were $3 million during the first quarter of 2018 compared to $2.2 million in the first quarter of 2017. This increase of $0.8 million primarily related to an increase of our field sales headcount and personnel-related expenses of $0.3 million and $0.3 million related to market development activities. General and administrative expenses were $3.2 million in the first quarter of 2018 compared to $2.7 million last year. This increase of $0.5 million is primarily attributable to $0.3 million of expenses related to executive transitions and the remaining increase relates to outside services and infrastructure costs. Net loss for the first quarter of 2018 was $9.8 million or loss of $0.17 per share. This compares to a net loss of $7.5 million or loss of $0.16 per share in 2017. Our non-GAAP net loss which excludes stock-based compensation and changes in our excess inventory reserve both noncash items was $0.14 per share for the first quarter of 2018 compared to a non-GAAP net loss of $0.16 per share in the first quarter of 2017. A full reconciliation of our GAAP net loss to our non-GAAP net loss including a per share reconciliation can be found in the tables at the end of our earnings release. Moving onto the balance sheet, as of March 31, 2018, we had $5 million of cash and cash equivalents and we carry no debt. As announced this week, we received $10 million in gross proceeds from our private placement of common stock at the market price with entities beneficially owned by our Chairman Gregg Williams. His funding provides us with current year working capital to achieve key commercial and development milestones for Argus II and Orion programs. With that, I will open the call for questions. Operator, please proceed with the instructions.

[Operator Instructions] And our first question is from the line of Dallas Salazar, please proceed.

Hey guys, thanks for taking questions. I have a few here. So if we can work through them. The first one I have is regarding the Argus implant ramp in Q2. Can you talk about any level of optimism that you have and then further how you expect the ramp to conclude into year end.

Sure Dallas, this is Will, I'll take that. In short, we're optimistic about Q2. I can tell you right now we have about 20 surgeries that are either complete or scheduled for the quarter. Now keep in mind that some of those surgeries are scheduled could be rescheduled for a future period, but also on the flip side, we still have plenty of time left in the quarter to have additional surgery scheduled. But at this point, we have about 20 that are either completed or are scheduled to occur. So I think - in short, I think it'll be another strong quarter for us in Q2. As for the remainder of the year, I expect growth - continued growth. As I've said many times before, if you look outside of North America, we're going to have much more fluctuations with our business there. The Europe, Middle East, and Asia consist of different markets, some direct, some distributors, some with reimbursement, others without reimbursement, and in some cases, we don't even have product registration. But over time, that business will definitely grow and I would expect the quarter to quarter fluctuations to become smaller through time. As for North America, I do expect meaningful growth for the remainder of the year starting with Q2. I'm optimistic because we have a growing patient database as I mentioned during the call, 160 patients that have been clinical qualified at this point. I also mentioned that we've increased our team; a year ago, we probably only covered about 60% of the US, now, we're covering probably 100% or we are covering 100% of the U.S. And then we're adding Centers of Excellence, our new centers. We added one in Q1 and so far in Q2, I think we've signed contracts and hopefully we'll do surgeries with two more new Centers of Excellence in the U.S. in Q2. So I think a lot of indicators would tell me that Q2 is going to be good in the US and the remainder of the year will be quite strong in the US as well.

And just to clarify that your outlook is baked on the assumption of zero label expansion for Argus, is that right?

That's right, that's right.

And just on that, really quickly if I ask kind of a part B to that. Like can you elaborate as to maybe the stage progress you've made with conversations with the FDA or just any color at all sort of in the background?

Sure. I can't say too much other than we made - we had a submission to the FDA, we actually had a phone call in the last couple of weeks with the FDA to discuss that submission and we will be scheduling another call with them here in the near future. And what we're trying to do through these discussions is just get a better understanding of the scope of the label change that they would consider appropriate under our HDE approval. So let's say one conversation down, another one to go, and then potentially there would be another submission to the FDA to try to get to a point that they're comfortable with. To be clearer, we remain very excited about the opportunity to treat these better vision RP patients. We think they'll respond really well to Argus, in general, they're going to have a less diseased retina. It's also a much better - a much larger market with as much as a 3x increase in the patient population which is I just said a minute ago would translate into the ability to a significant increase in the number of patients treated by each of our Centers of Excellence. So, would really allow us to get more of our investment in the commercial organization. So, very excited, hopefully, we'll have some positive news to report here in the near future.

And then just to round out my questions here and this is the last one, I promise. Regarding kind of expansion of market and some of the things in the pipeline, any more color you guys can provide on the Orion patients and then, any additional kind of anecdotes on the testing that you're conducting? And I'll jump back in the queue.

Sure. I mean the Orion patients, if I were to - I can describe them generally, we can't disclose any confidential patient information, of course. But, first of all, they are all excited to participate in the trial. These are patients who are blind and who have no other option out there to regain any sort of their vision. So Orion is very exciting to them as it is to us. I would also say there's a wider range of ages than we typically treat with Argus. A typical Argus patient is older. Here we have two of the four subjects that are much younger than our typical Argus patient. And I'd say on average also we think that they're probably going to be blind for a shorter period of time. And then finally, if you look at these first four patients, they are blind for three different reasons. So again, we're not just focused on one disease or one type of blindness. So it's really a large swath that we cut and as we said before, we can treat almost any form of blindness as long as they have a functioning visual cortex and there's not a technology or a therapy that's currently approved to treat them like Argus. The testing, maybe a few more comments on the testing, and I'll kind of go through what I did in this script and maybe explain it a little bit better. We are trying to go through three phases of testing right now. And the first phase involves - and which we've done with the first two patients, it involves especially energizing each one of the 60 electrodes and then we go through a process of basically fine-tuning each one of the electrodes at certain parameters we can change to fine-tune it and get the best possible light or spot of light if you will with the patient. So we've done that. We were thrilled to death to get light from each one of the electrodes on both patients. I would say that was exceeded my expectations there. We've now moved to phase two on both of the patients. And that's where we'd create a spatial map, and again, what we're trying to do there, Dallas, is we will again go through and kind of energize each one of the electrodes, it creates a spot of light in the patient's visual field, patient then has a touch screen in front of them that they will touch to indicate where they're seeing light in their visual field. And we go through that and we repeat it over and over for each one of the 60 electrodes so that we can establish then a connection between each electrode and where we'll create light in their visual field. And that has gone really well. It's repeatable and it's reliable. So, for example, when we energize electrode 23 on patient one, we're getting a spot of light in the same point in their visual field is not dancing around or moving around. So that's really important for us to be able to complete or to develop artificial vision for them. And then finally the last phase is, we take this spatial map that we have and we create an algorithm that we can use to take images from the camera and now we know to replicate those images with the patient now we know which electrodes to energize and to power to create the scene or the object or other things in front of the patient. So that's a process that we're doing now. And as I said, we just turned the camera on on the first patient and just starting that process, but you know that piece, well, I'd say the first phase where we create spots of light quite exciting for the patient there. One of our patients commented that wow that's the most beautiful spot of light I've ever seen. But then it becomes somewhat repetitive. I mean it's hard work for the patient, but then when we get to the point where we have a spatial map created and we are turning on the camera, again, I'd say it gets really exciting for the patients and I'm really looking forward to doing that with these first two patients and eventually with all patients, but really looking forward to doing this testing with the first two patients here over the next 30 to 60 days. Hopefully, that answers your question or questions.

No, it does. The risk of other folks kind of being upset that I'm taking a little bit more liberty here, but you did, you sort of caused me to ask just another follow up here, which is you know regarding that the path to commercialization for Orion and the breakthrough device program. What type of impact does that have on the path of commercialization? I know that you're getting ultimately familiar with the regulatory processes here including FDA and [indiscernible] some of these things. So what can you take from some of your history with getting things approved through regulatory bodies and how would that break the device program, how does all that factor into the path to commercialization for Orion?

Yeah, got it. A few comments, first of all, the breakthrough device program is designed or was designed by the FDA to basically assist promising new technologies that treat an unmet clinical need to get them to commercialization faster. So, we view it as a very much a positive for us. And so, the way it works is and we just submitted our first application to the FDA - our first document to the FDA. And basically in that document, we won't get into the details, we don't want to disclose the details yet, but in that document we lay out what we think should be done with the feasibility patients, so the first five patients, a type of follow-up should happen and what we should see from those patients. Then we also propose what should be done with the pivotal trial, so the approval trial, how many patients and what type of endpoints and what type of follow-up, the length of follow-up that we think is appropriate. And then finally, we propose what we want to or what we think should happen in the post-market setting. And the post-market setting is after we receive commercial approval, we'll continue collecting data to support the safety and efficacy of the product. So we have proposed all of that, it will now be a back and forth with the FDA and we want to get to a point sometime later this year where we have agreement with the FDA. And the advantage of that is, of course, we can share it with you and then you know what kind of timeline you should be thinking of to get Orion to market, you could take that timeline and number of patients and start translating into dollars of expenses and things like that. And it allows us to understand that entire pathway much earlier. So, expectations I'd say, again, just generally speaking with a breakthrough device the intent and what we would expect is that we can in the feasibility and then in the pivotal or approval trial that as opposed to a non-breakthrough device designation, we would implant a smaller number of patients to get the initial approval and then the follow-up on those patients could perhaps be shorter as well before we would get a commercial approval. And then to fill out the dataset if you will for the FDA, we would continue collecting data post approval in the post-market trial with agreed to endpoints and follow-up with the FDA and along the way provide all of that data to the FDA. But the advantage of the program should be getting us to commercialization sooner with perhaps less cost and less patients.

[Operator Instructions] And we have a question from Amit Dayal from H. C. Wainwright & Co. Please go ahead.

Congrats on all the progress with Orion, really exciting stuff. I know you answered a lot of the questions on Orion. Maybe just one question for me on that front is, first patient seems to be slightly ahead of the others in terms of the stage of testing et cetera. So what are the next steps for this patient and how does that maybe situate you with discussions with FDA et cetera?

So this patient, we have just - the first patient we have just turned the camera on, so I would say over the next - I don't know the time period, but I'll say the next 30 to 60 days what we will do is we will be doing more and more work with the camera on and basically we'll start feeding live video, so real-time video. So we'll have the entire Orion system working. They'll have just like an Argus system, they'll have a camera capturing video in front of them and we have the algorithm developed and each algorithm right now is developed specifically for each patient because we do an individual spatial map for each patients. And we'll start developing and producing artificial vision for this patient. And they can start using it to walk around and do task and things like that. So it gets really exciting now with this first patient. And then per the protocol, at some point after we get to a certain point in the testing, per the protocol the patient would then be able to actually take the system home and start using it outside of the setting in the lab. And so that would happen here at some point in the near future. I don't know the exact timing of that, Amit, but at some point in the near future. And then the second patient is going to be maybe 30 or 45 days behind that patient. And then patients three and four, we just recently implanted them and we expect that we will probably have the initial activation session in the next couple of weeks for each one of those patients. And so that's where we will start activating each one of the electrodes individually for those patients. And then finally, as I said, hopefully, in the near future, certainly we think before the end of this quarter, we'll enroll the fifth patient out of five that we're agreed to for the feasibility study.

And just out of curiosity, so this is just turned on while you guys are doing testing or is it turned on at other times for the patient?

Good question. So, right now, it is just turned on in a controlled environment at the hospital while we're doing testing and that's because we want to do testing with someone there and we're watching them very closely to make sure there's no adverse events or pre-seizure or seizure type activities of which we have not seen. Still, we want to watch closely and get a high confidence that the system is not going to cause any adverse events or unexpected adverse events with the patient. So, we'll be getting to that point here hopefully in the near future with patients one. And then at that point, we will basically say you can now take the system home and start using it without us overseeing it or without someone from UCLA or Baylor overseeing the use of it. So getting closer to that, we're not there yet, Amit, that's certainly to goal.

Just on the Argus II side, we saw 30 implants in the fourth quarter, 16 implants in the first quarter of 2018. Can you help us understand what is driving some of this variability, is it just the queue of the patients you're screening to get in line for the implant and going forward, is this type of variability going to continue to play out?

Good question. It's a lot of different factors, outside of North America is the most variable. I think even from 2016, I believe it was in Q4 outside of North America to six. And again that's just that's a lot of factors driving that variability. There may be a few units that ordinarily would have happened in Q1, maybe the team pushed to get it at the end of the year. But that's just driven by variability in each one of the direct and indirect markets there. We did show a sequential decline in the US as well. Much less like 14 to 4 if I recall, so…

To 10.

To 10, I'm sorry; it's a 10, 14 to 10, difference of four. And I would expect to see less variability in the US or in North America should I say going forward, Amit, because in the past, if you take last year, let's take last year in North America, we had a much smaller team, we would do say even in the fourth quarter we implanted ten patients, but the team it was - at that point, it was a bit of a stretch for the team to do the implants to do the activations to get rehab going and things like that. So I would say we were kind of stretched parts of last year as far as our manpower or person power in the US and in North America. We don't think that's an issue going forward. And we also have quite a - as is said one new site in Q1, two more sites we think coming on in Q2 and then quite a few in the second half of the year. So I think you're going to see more consistent growth both versus prior year versus prior quarter in the US for the rest of the year, but I do think as I've said many times you'll see some variability outside of the US and it will be some time before we eliminate that variability. But again, very, very optimistic about the North American situation and the ability to do consistent growth quarter to quarter going forward.

On the cash front, the commentary of the call indicated that you guys aren't good until the end of the year. But looking at sort of your expenses in the first quarter, it looks like included the 10 million placement that just happened, we have maybe another two quarters worth of sort of - unless I'm reading this wrong. So could you help me reconcile this, please?

Hi Amit, this is John. With the recent financing, I projected that will extend our runway into late Q3 or early Q4. And importantly that will enable us to execute on the key milestones in our Argus II and Orion programs that we talked about earlier. And most importantly will be able to report on the interim results with our first five subjects in the Orion feasibility study regarding safety and efficacy. So we really believe that this financing takes us to a position later in the year to be able to achieve a lower cost of capital.

Just one final one from me. Are reimbursement rates holding steady for you guys, any changes on that front?

No changes since the beginning of the year. Our average reimbursement in the US for the device and the procedure is 122,500. As we talked in the past that's an average, the actual reimbursement could vary based upon geographic location. So higher cost areas have a higher reimbursement, lower cost areas have a lower reimbursement. And so the one thing that could cause the US reimbursement to vary quarter to quarter would be just actual location of the implants. Outside of US, I don't think we had any in changes in our reimbursement and the Canadian reimbursement is - reimbursement in Ontario is very close to and very much in line with the US, maybe actually a little bit more than the US. So good strong reimbursement in Ontario as well.

Just wanted to add that given our overall geography mix that we project this year favoring the North American region versus Europe that will support ASPs to be as good or better than what we had in 2017 overall.

I was going to ask what kind of reimbursement rates on average we're seeing in the international market.

I think we're seeing in the 90s. So, some variability there between the indirect markets and some of the direct markets, but I think it's pretty consistent - our ASP there is pretty consistent, Amit, with what we've reported in the last couple of years somewhere around 90,000, maybe in the low 90s or something like that on average.

I believe that's all the questions or time for questions we have at this time. I like to hand it back to Will McGuire.

Thanks again everyone for joining our call today and I look forward to providing an update on our next call. Have a great day, thanks.

Thank you.