Second Sight Medical Products' (EYES) CEO Will McGuire on Q2 2016 Results - Earnings Call Transcript

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Second Sight Medical Products (NASDAQ:EYES)

Q2 2016 Results Earnings Conference Call

July 28, 2016 04:30 PM ET

Executives

Lisa Wilson - Investor Relations

Robert Greenberg - Chairman

Will McGuire - President & Chief Executive Officer

Tom Miller - Chief Financial Officer

Analysts

Sameer Joshi - Rodman & Renshaw

Operator

Ladies and gentlemen, thank you for standing. Welcome to the Second Sight Second Quarter 2016 Earnings Call. During the presentation, all participants will be in a listen-only mode. Afterwards, we will conduct a question-and-answer session. [Operator Instructions] As a reminder, this conference is being recorded today Thursday, July 28, 2016.

I will now turn the conference over to Lisa Wilson, Investor Relations for Second Sight. Please go ahead.

Lisa Wilson

Thank you George. Good afternoon, and welcome to Second Sight's second quarter 2016 earnings call. This is Lisa Wilson, Investor Relations for Second Sight. With me on today's call are Dr. Robert Greenberg, Chairman of the Board of Directors; Will McGuire, President and Chief Executive Officer; and Tom Miller, Chief Financial Officer of Second Sight.

After the close of market, the company issued a press release detailing financial results for the quarter ended June 30th, 2016. 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 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 July 28th, 2016. Since then Second Sight may have 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 Chairman, Dr. Robert Greenberg.

Robert Greenberg

Thank you Lisa. Good afternoon and thank you all for joining us on today's call. I want to first share with you three encouraging recent events. First is our oversubscribed rights offering that took place in May, giving us access to more than $19 million in cash. We very much appreciate the strong show of investor support. As part of the offering we issued approximately 6 million shares of our common stock for the price of approximately $3.32 per share. The proceeds will allow us to continue funding the ongoing post market clinical study of the Argus II to continue accepting the safety and efficacy of the Argus II for the treatment of AMD and to expand our global reach and bringing this life changing technology to patients who can benefit. The proceeds will also go towards funding the ongoing development of the [indiscernible] cortical prosthesis, a visual prosthesis for cortical simulation which should be able to treat nearly all forms of blindness.

The second noteworthy and significant event is a recent posting by the Center for Medicare and Medicaid services or CMM held a proposed rate for calendar 2017. The new rates if finalized would raise the 2017 reimbursement level for the Argus II and associated [indiscernible] procedure to a $150,000 up from the current rate of $95,000.

And finally in the medical journal Ophthalmology [indiscernible] five year data was recently published supporting the long term safety and benefits of the Argus II, results in that paper showed that patients' visual function improved after implantation and importantly that those results were sustained over time for many years. The Argus II also has acceptable safety profile, patients reported that using the Argus II has [indiscernible] impact.

Our commercialization and R&D efforts are on track and we remain poised for future growth. We've made some organizational changes recently that we believe will greatly strengthen our sales teams. We have also refined our strategy to focus on geographic centers of excellence to drive greater competency and patient volume. This fine tuning will enable us to bring greater value around patient identification, evaluation and post procedure rehabilitation. On the R&D front we're evaluating patient performance from our dry AMD trial and expect to have more information around this trial to share with you later this year.

We continue to focus on enhancing the externals for the Argus II and our plans to file with the FDA for approval of its next generation product around the end of this year. The Orion project as well is progressing as expected. We are in the process of expanding and evaluating the histology from the pre-clinical study with our unchanged goal performing the first Orion implant in a human in the first half of 2017. In a moment Will McGuire will provide more details around the use and other priorities but first Tom Miller our CFO will review our second quarter financial results. Tom?

Tom Miller

Thanks Bob. Excuse me. For the second quarter of 2016 net sales grew $1 million compared to $2.7 million in the second quarter of 2015. This decrease was driven by lower implant volume and lower revenue per implant. A total of 11 implants were performed in Q2 2016 compared to 20 in the second quarter of 2015. Our average revenue per implant was $94,000 in the second quarter of 2016 compared to a $133,000 in the second quarter of 2015. The lower revenue per implant reflects the reduced CMS reimbursement rate, the timing of revenue due to certain deferred deal terms and certain incentives provided to customers.

We generated a gross loss of $2.2 million in the quarter compared to a gross profit of $1.1 million in the second quarter of the prior year. This gross loss is the result of approximately 1 million in revenue plus $3.2 million in cost of sales. The cost of sales breaks down as approximately $700,000 of product cost, approximately $1 million of unabsorbed production cost due to a lower production volume and a one-time $1.5 million adjustment for excess inventory.

We have taken certain steps to reduce our manufacturing costs and we'll continue to monitor our inventory levels. At the appropriate time we will resume normal production levels of Argus II implants. Until then we expect to continue to generate gross losses. We still believe that the Argus II will generate a solid positive gross margin as sales ramp up in future years. R&D costs, net of grant revenue were $916,000 compared to $849,000 in the prior year quarter. This change represents an increase in spending of $260,000 offset by a $193,000 of additional grant revenue in the current quarter. We are spending on important product initiatives like our new externals and the Orion 1 implant.

Clinical and regulatory costs decreased to $568,000 compared to $892,000 due in part to lower new enrolment rates in post market clinical trials. Selling general and administrative costs increased from $4.3 million in the second quarter 2015 to $4.8 million in the second quarter of 2016. Approximately a $109,000 of this increase related to higher stock based compensation cost, including these non-cash cost SG&A expense increased by 10% in the second quarter of 2016 compared to the second quarter a year ago mainly related to key new hires and customer outreach programs.

Our net loss for the second quarter of 2016 was $8.5 million or $0.23 per share, this compares to a net loss of $4.9 million or $0.14 per share for the second quarter of 2015. We recorded non-cash charges of $2.3 million during the second quarter consisting of stock based compensation of $802,000 and a $1.5 million reserve for excess inventory. This compares to non-cash charges of $640,000 in the second quarter of 2015 which was for stock based compensation. Excluding these non-cash charges, our non-GAAP net loss for the second quarter of 2016 was $0.17 per share compared to a non-GAAP net loss of $0.12 per share in the second quarter of 2015.

A full reconciliation of our GAAP net loss to our non-GAAP net loss including the per share reconciliation can be found in the tables at the end of our earnings release. We completed our successful rights offering on May 31 and distributed shares to investors in early June. We raised $19.5 million net of cash offering cost selling approximately 6 million shares at $3.315 per share to over 1000 existing shareholders. We were pleased with the high level of participation. With that cash in the bank as of June 30, 2016 we had $23.9 million of cash in money market funds and no debt. Based on our current sales and expense projections we believe that is sufficient cash to fund our business for at least the next 12 months. With that said I'll turn over to Will.

Will McGuire

Thanks Tom. Q2 was another challenging quarter for implant volume and revenue. Our US business rebounded slightly from Q1 but was still below historical 2015 levels, if you will recall our selling price was approximately $50,000 over expected Medicare reimbursement for much of Q1. When it became clear CMS did not intend to adjust 2016 reimbursement, we began discounting our technology in late February. We then started revising some purchase agreements and encouraging customers to restart the process of assessing potential patients for Argus II eligibility.

We did regain some momentum in the latter half of Q2 and ended the quarter with four US implants. We also had positive change in Q2 in the North American field team with a new commercial VP coming up to speed while simultaneously recruiting a new East Coast sales director. As the new team is coming together a few exciting opportunities have emerged and one in particular is our revised Centers of Excellence program or COE. In the coming months we'll be formalizing exclusive original partnerships strategically placed across North America. This will involve expanding our mutual roles with many of our existing customers and it will be the lead criteria for us as we continue our expansion. The goal of this program is to establish implanting centers and physician clinics that are more intimately knowledgeable, self sufficient and confident. This will be further supported by the added resources we will provide these centers.

As a result we expect them to be able to treat a higher volume of patients. Our established COEs will also address several opportunities for growth one of which is the significant number of eligible, motivated patients who are otherwise on hold for a variety of reasons. This includes many prospective patients who don't have access because they would need to travel 200 miles or more to a center for screening, for surgery and for post surgery programming. And after that they need to go through extensive rehabilitation to learn how to use their artificial vision.

Even if the patient believes they can overcome the distance problem it's not uncommon for the physician or center to put a surgery on hold until there is a satisfactory solution for the patient to obtain rehabilitation locally. A high priority over the next six months is to build a stronger network of post surgery support, provide much higher number of qualified eligible patients can move forward with an Argus procedure. In addition to our COE program we have greater impact today on the information that is most helpful and relevant to prospective patients as they make their decisions to move forward with the surgery. We're integrating a market leading automation platform that will allow, that will enhance our efforts to communicate with our expanding patient database.

This new platform will help us to keep prospective patients updated on the information, provide ongoing support and when appropriate connect them with one or more of our COEs. We are very confident that our efforts to strengthen these relationships with the centers of excellence and prospective patients will lead to an increase in the number of patients treated in the US. In Europe, Middle East and Africa or EMEA we had a total of seven implants during Q2. This was below our 2015 average but recall that many of the markets managed by the European team are inherently lumpy due to the small size of our business. We have seen some recent activity from competitors in Europe and it's possible that we've lost a few cases as they recruit patients for regulatory and or reimbursement approval trial. We expect the European competitors near term impact to be limited by their lack of long term clinical evidence and reimbursement coverage. As in the US we've also made a few organizational changes and additions including a new head of international sales for indirect markets. Speaking of indirect markets we announced two new agreements today. The first agreement is in Taiwan, with Orient EuroPharma a well established distributor deeply connected in the ophthalmology market.

Taiwan is a densely populated state of 25 million people, the healthcare system is one of the most advanced worldwide with a structured social security system managed by the Bureau of National Health Insurance. Our second agreement is in Iran with [indiscernible] a company with a proven track record of introducing similar medical devices and building multimillion dollar businesses. Iran is a large market with approximately 80 million people. The department of treasury has granted us approval to sell our product in Iran and the next steps in both markets is to pursue regulatory approval and secure reimbursement or other sources of funding for Argus implants.

As Bob mentioned some really good news, though not final yet is that on July 6th CMS posted the proposed rules for the 2017 Medicare hospital outpatient prospective payment system establishing a proposed Medicare hospital outpatient rate of a $150,000 for the Argus II and the associated surgical implantation procedure after hearing comments from various stakeholders including hospitals providing the service and reviewing the 2015 hospital claims data we're pleased that CMS has proposed this new payment rate and the associated new technology APC. Along with other stakeholders including our hospital customers we will be submitting comments to CMS in this regard by September 6th 2016 which is the comment deadline. As with all proposed rules they are subject to change and there is no assurance that the payment rate will remain at a $150,000.

We anticipate the final rules will be published in November 2016. Also want to note that this proposed rule only affects Medicare fee for service payments to hospitals and does not directly alter Medicare advantage or private insurer payments. Along the topic of US reimbursement, we also recognize the need for a mechanism for the clinics to build their charges for programming services in connection with Argus II. There a simple amount of work that is performed by highly trained healthcare professionals to ensure that the patient is experiencing the maximum benefit of advice and we believe this should be reimbursed. In June we submitted a category three, CPT code application for programming services in the US. If approved AMA CPT will publish the code in the January 2017 CPT code book and it will be effective January 1, 2017.

During Q2 we continued to make progress towards obtaining reimbursement in the UK. As previously announced Argus II is being considered to be funded under commissioning through evaluation, such programs generally known as coverage with evidenced development are becoming increasingly common in major EU markets and allow for conditional reimbursement for innovative breakthrough technologies and procedures such as the Argus II for more long term data is collected.

The detailed arrangement and the timetable for a final decision have not been announced but it is likely that this will take place later this year. We're encouraged by the progress in the UK and we'll keep you updated. As announced this past Thursday we are very pleased with the five year data from the Argus II clinical trial has been published in the medical journal Ophthalmology. The paper entitled five year safety and performance results from the Argus II retino prosthesis system clinical trial follows the assessment of the original 30 subjects who were implanted with the Argus II in 10 clinical centers in the US and Europe. As part of the study three types of visual function tests were performed using computer run assessments. Square localization or object detection, direction of motion, or motion detection, and discrimination of oriented gradings for visual acuity.

Two types of real world orientation and mobility test were also performed. A test where patients were asked to locate and touch a door and a test where patients were asked to follow a white line on the floor. The long term results were compelling and present a milestone in the fight against blindness. It's extremely gratifying for us to know that the benefits reported by patients receiving the Argus II endure for many years after implantation. As European competitors start conducting cases in order to obtain regulatory and or reimbursement approval, we’re convinced the long term data supporting the Argus II provides us with a significant competitive advantage into the foreseeable future.

One final reimbursement note, now that our five year data is published we will be reengaging many of the US Medicare administrative contractors or MACs in non coverage jurisdictions with our key opinion leaders in order to influence a favorable coverage decision. I am hopeful that we could see additional favorable coverage decisions later this year or sometime in 2017.

Our research and developmental efforts remain focused on several key areas, first developing enhancements to our Argus II technology to increase patient satisfaction while improving outcomes. Second, conducting additional clinic work to expand the patient population we serve and finally expanding into direct cortical stimulation with the development of the Orion 1. We’re investing in Argus II enhancements that we believe will allow current and future patients to enjoy better more useful vision utilizing the current implant. As discussed in past calls we continue to focus on improving the externals including the eyeware, the camera and the video processing unit or VPU.

The new more powerful VPU facilitates more sophisticated software enhancements and an improved user interface. We are on course to file for FDA approval and CE mark regulatory clearance for next generation platform externals around the end of the year or early next year. We will begin patient testing of the new software and filters such as improved contrast or edge detection, new stimulation strategies and soon before the end of 2016.

Commercial roll outs of these exciting software enhancements on the new platform are dependent on the outcomes of testing and additional regulatory approvals. We are continuing to evaluate Argus II in populations of low vision patients, such as those with dry AND, some initial data from our AMD feasibility study were recently presented by a Professor Stanger from Manchester in the UK at a prestigious conference in Bordeaux, France. The presentation attracted a great deal of interest from many of the surgeons in attendance. Professor Stanger reviewed safety data, the preservation of patients' native vision and the ability of patients to integrate their new artificial vision with their native vision. The focus moving forward is to better understand the resolution and usefulness of the combined vision. We are pleased that this work is gaining exposure and generating discussion. As we continue to evaluate all the data on patient performance we'll have more detailed information concerning our path forward. We also had the first implant of Argus II in a Stargardt's disease patient in Florence Italy by a Professor Rizzo. The surgery went well and the patient is beginning the rehab program. Some Stargardt's patients are within our European label and if results look favorable we expect interest from additional patients in this treatment. Finally as discussed by Bob the Orion program which allows us to leverage our Argus technology and expand into direct cortical stimulation continues to progress. We're starting to expand some of the preclinical arrays and we'll be analyzing histology in the coming months. We remain on track to submit an IDE to the FDA around the end of the year requesting approval for starting human feasibility study in the first half of 2017.

Overall I am encouraged by recent events. The rights offering and the potential for a higher Medicare outpatient payment rate for 2017 will enable us to continue efforts to build awareness and provide Argus II to those in need. Similarly our restructured sales teams will leverage their deep experience and should drive the rebound in second half of 2016 implant volumes. Our position as the dominant industry player reflects our extensive patent portfolio protecting our work our ongoing technological investments and the growing evidence of the safety, reliability and longevity of our products. Thank you for your continued interest and support. With that I’d like to open the call to questions. Operator, please go ahead with the instructions.

Question-and-Answer Session

Operator

[Operator Instructions] And our first question comes from the line of Sameer Joshi with Rodman. Please go ahead.

Sameer Joshi

Hello guys, the first question relates to the gross margin, we have negative gross margins this quarter and I understand it is because of the 1.5 million inventory adjustment and the overhead cost of 1 million. When should we expect this 1.5 million excess inventory to go away in the future.

Will McGuire

Well, that's a one-time adjustment that impacts the second quarter so we would not expect that to be a recurring entry, I mean we'll look at inventory going forward but we wouldn't expect to book that order again, that adjustment again, whereas the unabsorbed production costs could be a recurring cost, will be a recurring cost until we get our production levels up.

Sameer Joshi

So, what is the breakeven for gross margin, like at what level do you get gross margins positive of revenue?

Will McGuire

Well, it’s not so much a question of revenue, it’s more a question of production, and we never really talked about that specifically but what has to happen is the production levels have to go up to absorb these production costs. And if you look at our historical financials and you look at 2013 and first half of 2014 we had the same issue where we had low production volumes and that resulted in a lot of unabsorbed production cost. Our production ramped up in the back half of 2014 and through 2015, and we were able to make more products and absorb all those costs. So it's really a question of producing more, which will do when we see the quarterly implant volumes picked up.

Sameer Joshi

On the implants, I heard on the call of four U.S. and seven in the EMEA region. Is that correct?

Will McGuire

That is correct.

Sameer Joshi

And also the four U.S. implants, did they occur after the new VP was hired, or like what was the time line?

Will McGuire

They were after the new VP was hired, and at the end of Q1 and then all four of these implants I believe were Medicare patients which we had zero Medicare patients in Q1. The one U.S. patient we had in Q1 was a VA patient. And actually three of the four implants occurred in the second half of the quarter. It took us some time to work through purchase agreements and for the centers to actually screen and screen patients and schedule surgeries. So this is the uptick saw was in the second half of the quarter.

Sameer Joshi

So going forward are you optimistic, because last quarter was 10 implants, this quarter is 11. Are you optimistic that it will ramp up? And are these steps that you’re taking by hiring these specialist sales people. Do you think they’re enough to achieve that goal?

Will McGuire

Yes, I think a couple of things will help us. One, is now we have the discrepancy between our pricing and reimbursements in Q1 and we’ve got purchase contracts and in the process of screening and scheduling patients. And then number two as we said, we’ve hired a new sales VP, takes a little bit of time to come up to speed, but he’s come up to speed nicely and is in the process of implementing our revised centers of excellence program, which we think is going to be a big plus for us.

It's going to really build centers with more capabilities, more capabilities for screening, for evaluating surgical support, as well as more capabilities for the post surgery programming. And then as those centers become more confident and able to treat more patients, then we will focus a lot of our outreach programs around those centers. And we also have made some progress and improved our outreach programs. So that I’d say in general we’re having better deeper conversations with the patients and we’ve got mechanisms in place to stay very close to these patients going forward. So that we -- and continue to address their concerns. And as soon as possible, put them in touch with the appropriate center to schedule a case. So it's a long weighting answer, I guess.

Sameer Joshi

No, but that’s good. But going for on a 2016 annual basis, do you expect to reach close to the total number of implants you did in 2015? Or more or less…

Will McGuire

We haven’t really given any guidance to that respect. I would just say this that we expect second half volume to be stronger than first-half volume. And we expect to be that way, both outside the U.S. as well as in the U.S. And I continue to believe we have the most opportunities for growth in the U.S. given some of the expanded Medicare reimbursement we have and our ability to potentially open additional centers in large population centers, such as New York or Boston where we currently don’t have a center, and we do have Medicare reimbursement. So still think we can grow in both geographies but probably more opportunities right now in the U.S.

Sameer Joshi

At the end of last quarter, if I remember correctly, there were 34 centers. How many centers do we have now?

Will McGuire

We didn’t add any centers in Q2, so there were no changes to the number of centers in Q2. We took a break, especially in the U.S. as we revised our centers of excellence program, just to make sure that any new centers we brought on-board would kind of fit this model. And again it's a model where we don’t expect higher volumes but we’re going to provide more support. And so we paused what we’re doing there. I can say this. We’re not going to project how many centers we’ll open in the remainder of the year, but in the U.S. we’re in discussions with five more centers right now that some may, some may not materialize. These are actually new centers for us. And in Europe it's about the same number. We’re probably in discussions with around five centers that all of them may or may not materialize as new centers in the new future.

And then also in the U.S. we have a couple of centers that did a case a while back and had not done any cases in some period of time. And maybe sense to another initial case we’ve got in Medicare reimbursement in that region, and we’ve now reengaged those centers and hopefully we’ll resume doing implants with those centers in the near future as well.

Sameer Joshi

Coming to the CMS rate, I mean, I know you have to do comments and by November you expect the final decision. What are the chances that it will be, the amount will be, adjusted upwards than….

Will McGuire

I really can’t handicap that. I mean a change -- for a change to happen the most likely way for that to occur would be if new information was presented to CMS, or if there was some realization that some of the data that they use was incorrect. So that’s one thing that we’re doing is just taking a look at everything that’s available to interrogate the data and see if we think everything was calculated appropriately. We’ve got no reason to believe that it wasn’t.

At this point, there is some other events are happening that led them to want to make a change. But for the most part the rate is based upon the claims data. And that claims data has been out there for some time. They have scrubbed it and calculated this rate. So, our expectation, I can’t handicap it, but our expectation is that when the final rule comes up that the rate will be 150 or something fairly closer to 150. But again we have no way of handicapping that.

I will say also I mean we will be in touch with CMS and we’ll make the appropriate comments during the comment period. And if at any time we think something is headed in a negative direction, we will of course try to intervene and correct it.

Sameer Joshi

And one last question. Could you just give us some more details on what you have been seeing in the A&D patients?

Will McGuire

Sure. I think Bob will probably take that.

Robert Greenberg

So, we’re going to be giving more detail in the coming months. But what we can say so far, there are few things that we do know of the five patients that were implanted. Our first question was is near vision preserved in new patients and we were putting in an implant in the A&D patients unlike our few patients had some peripheral vision. So it's important to know whether near vision is preserved. And the good news is so far it appears that the vision is preserved in these patients to not too significant degradation in vision applicant in the [RS2]. So that was long question.

Another question that we had going into the study was whether patient is going to be able to see something centrally, these patients with an [indiscernible] blind in their central area of vision. And a 100% of the patients who’ve gotten the implant so far have been able to see centrally where previously they couldn’t. And I think our third question that we had was, will patients like it? Will they be able to embrace artificial vision through natural peripheral vision? And the answer to both of those is, well they can, yes. We know now that the patients can -- they can use the implant and they like it. And so we’re very encouraged so far. It's only five patients, but these subjects like it.

Now there is still work to be done. These are the few questions just that we saw, and remaining are what are the actual resolution of the vision that they’re getting restored in their central area and how do we optimize the rehab, how do we demonstrate the real world improvement through rehabilitation and through test. So that’s where we are currently and over the coming months we’ll be reporting not only more data but also our go forward strategy for commercializing a mandate.

Operator

[Operator Instructions] Our next question comes from the line of [Dallas Salzer] with Atlas Consulting.

Unidentified Analyst

I had a hard time buzzing into the queue line, so if you already answered these, I’ll just catch them on the replay, but just two quick ones. What other additional information can you provide on the visionary published, five year study, if any?

Robert Greenberg

I’ll take that one. So, I think there is number of things that are important in our five year study that we reported last week that was focused on ophthalmology. I think the -- probably the most important is that the data is really impressively consistent all the way out over five years. So these patients had, and we published previously three year data, and these patients had visual improvements in visual function out to three years. And now this latest paper shows that that vision continues consistently moving out to five years.

Similarly, the devices that we provide for liability contains -- maintains out to five years, so these devices have been extraordinarily reliable as well. And so, I think the significance of that is twofold; one is that five years is a far that many people said as some of the important tip; the second point between what’s experimental and what is an established therapy and after the Argus now has crossed their threshold of five years and the established therapy should help on the number of the payers on the reimbursement front.

And similarly with competitors that are now beginning to do clinical trials in Europe, there is a significant difference between the competition, which is just beginning with some clinical trials in Europe, versus having long-term stable and reliable data out five years. So I think those are some of the points I would make of the data set.

Unidentified Analyst

And hopefully there’ll be some sort of mechanism or waiting on more about that as time goes on. The other question I would have is, are you all planning to open more centers in areas where there is favorable mat coverage in the U.S.? And are you pursuing now, can you talk about process stage, anything along that conduct?

Will McGuire

This is Will, I’ll address that. I’ve touched on it briefly. But we’re in the process of waiting these centers in the U.S. as I said earlier that we want them to fit our centers of excellence model. But certainly an important criteria for us is establishing centers in geographic areas where we have reimbursement, and we don’t have the center close by. So yes we’re hoping to establish several of those. And if you just look at where we have reimbursement and earlier that was where we have centers.

For example, we don’t have a center in the Boston area. We don’t have a center in the New York area. We don’t have a center in Virginia. So, there is some pretty popular areas right now where we have Medicare reimbursement in place but we don’t have a center and those would be high priority targets for us.

Unidentified Analyst

And then just as a quick follow-on, communicating that when things come to a certain level of visibility to the street. Is there something you guys would want to communicate through the process, or just when you get one in execution?

Will McGuire

Typically, what we’ve done is, when we’ve opened these centers we have communicated it during the quarterly calls. And so, I would imagine that we would do the same thing going forward. We didn’t open any new centers this prior quarter. So we didn’t have anything in the release or in the script about that. But certainly we would make people aware of it as we go forward in the quarterly calls.

Operator

Our next question comes from the line of [Ming Jiang] with Century Management. Please go ahead.

Unidentified Analyst

I’ve got a couple, first one, can you guys provide update on the backlog of patients who have passed your screening, and they look for, or are they awaiting a reimbursement clearance?

Will McGuire

Sure, this is Will. I can answer part of that, let me just find my notes here. So in the U.S. now we have approximately 185 patients in our U.S. database and these are patients that have been through a phone screen with us. About 40% of those have come from our direct outreach efforts over the past say six to nine months, which includes radio or other advertising tradeshows and foundation for fighting blindness, chapter meetings things like that.

And of that 185, we’re, as I mentioned earlier, we’re developing an even closer or more in-depth dialog with these patients. And based upon that right now and where we have centers or where we think we’re going to have centers, we see a conservative number of 30 of those that we have some confidence that we can convert into surgeries over the next, say nine months. It may be more than that. But we’re certainly optimistic based upon all of our conversations with the patients.

It's just a matter of putting into place some of the things I talked about earlier, including new centers in key areas where we have reimbursement, but also putting into place a broader network of rehab specialists or rehab capabilities. So that when we do address the patient, it maybe of distance away from the center, when they go back home we are able to provide rehab, and the center and the patient are both comfortable that they’re going to have the necessary rehab available.

Unidentified Analyst

And then outside of the U.S., how is the patient screening done internationally?

Will McGuire

It's similar. We also do targeted radio advertisements, we even had -- we do input sessions in some towns. We’ve even had TV shows, dish specials all long that’s right here in the U.S. And so most of our efforts have been -- all of our efforts, I’d say, outside the U.S. have been focused in Italy and in Germany. And I got some recent data. For example, in Italy, all of our work that I just described provided like 958 leads year-to-date, which we’ve been followed up on most of those. And identified so far nine patients that were eligible, and these are patients that had actually in screen at the site. And out of that nine, seven have already been implanted.

And typically what happens in Italy is we identify these patients through all of this patient outreach work and then certain days or scheduled at various centers in Italy to bring patients in. So multiple patients would come in on a day and receive screening. We’ve done some similar things in Germany, not as widespread but year-to-date there, little over 450 leads were generated. 15 people are going to get screened, five were eligible and so far out of that five, two have been implanted. So, we start off with a pretty wide net and then you just narrow it down through phone screens and then screens at the actual physician or hospital.

Unidentified Analyst

And do you directly do the screening, or that’s your, I guess, through your distributors, in the net of distributors, do the screening for outside of the U.S.?

Will McGuire

Most of the work that we’ve done has been in direct markets. So we have direct people in Italy and in Germany. So, in those cases, we’re on the phone and maybe generating the initial lead. But then many times a follow up phone screen maybe done by the actual institution and certainly the physical exam will be done by the institution. But in Italy and Germany it's us leading the process with second site employees.

Unidentified Analyst

And then in the U.S., how much of your U.S. business is VA related and how much is Medicare?

Will McGuire

I am going to say Medicare is probably 90% to 90 plus percent, 95%. I can think of one or two VA patients that we’ve treated in the last year. I don’t have the exact numbers. But, we did treat one in the first quarter and I remember one VA patient the second half of last year but I am not 100% certain. But it's -- vast majority is going to be Medicare and that Medicare will be a mix between fee-for-service Medicare Advantage, and then we’ll also have added to the mix, there will be some private insurer patients as well. But again that’s going to be the small minority of the patients for us.

Unidentified Analyst

And then on the reimbursement environment in Taiwan and Iran, can you just comment on the general reimbursement environment and are they more or less both in the U.S.?

Will McGuire

It’d be hard for me to rate them versus the U.S. I mean there is an established reimbursement system, as I mentioned in the comments. In Taiwan, we will, after getting regulatory approval, we will be pursuing reimbursement, most likely in both countries we will end up doing a limited number of cases and getting some results from those cases and using it to pursue reimbursement. But as far as our likelihood, it's a little difficult to predict right now. We wouldn’t be pursuing those markets if we didn’t think we had the ability to get reimbursement. But the timing is probably more of a question for me.

Unidentified Analyst

Last one from me how much -- you guys probably mentioned it, and I probably missed this. How much cash was used in the quarter?

Tom Miller

We did not mention that. But cash from use in operations -- if you give me a second I can say what the quarterly number is going to be. Cash used in operations is going to be somewhere in the $6 million range.

Unidentified Analyst

And is that the quarter number or year-to-date number?

Tom Miller

It's somewhere around $6.1 million for the quarter. We had about $6 million number in the first quarter also. So, it looks like about $12 million year-to-date.

Operator

There are no further questions at this time. I’ll turn it back to the presenters.

Will McGuire

Thank you all for joining us today. We’re especially grateful to our shareholders who support our goal of making the dream of site a reality for blind individuals around the world. Have a great day.

Operator

Ladies and gentlemen, that does conclude the conference call for today. We thank you for your participation, and ask you please disconnect your lines.

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