Vivani Medical, Inc.
Q3 2016 Earnings Call Transcript

Published: 3 Nov 2016

[Operator:]

Ladies and gentlemen, thank you for standing by. And welcome to the Second Sight Q3 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 Wednesday, November 2nd, 2016. I will now turn the conference over to Lisa Wilson, Investor Relations with Second Sight. Please go ahead.

[Lisa Wilson:]

Thank you Collin. Good afternoon, and welcome to Second Sight's third 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. At the close of market, the company issued a press release detailing financial results for the quarter ended September 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 November 2nd, 2016. 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 Chairman, Dr. Rob Greenberg.

[Dr. Robert Greenberg:]

Thank you Lisa. Good afternoon and thank you all for joining our call today. We're pleased to share with you within in the third quarter and in the past few weeks since the quarter ended, we've continued to make important strides as we focus on expanding our global page and bringing life changing technology to patients who can benefit. And as we announced this morning, we are very pleased that yesterday CMS, The Center for Medical Services confirm in their final role that the Medicare hospital outpatient payment rate for 2017 have a 150,000 for the Argus II any implantation procedure, which is up from 95,000 in 2016. In a separate development, the AMA has approved our application, the American Medical Association has approved our application for two new Category III CPT Codes for initial programming and reprogramming the Argus II. With these new codes beginning in July 2017, commissions will have the ability to build for these critical activities. We are continuing to fine tune our US commercialization strategy with a focus on creating centers of excellence and forming distribution partnerships outside the US, steps that will lead to better alignment with partners and to the treatment of greater numbers of patients. Will plans to share more detail later in the call in this. Last week we announced the first successful implantation and activation of a Wireless Visual Cortical Stimulator in a human subject at UCLA. Providing the initial human proof of concept for the ongoing development of the Orion I Visual Cortical Prosthesis. This first human tests represents a very important milestone and confirms that we're on the right track with Orion I program to treat blind patients who cannot benefit from the Argus II currently. The stimulator using this test had only a few electrodes and did not have a camera but nevertheless demonstrated that we could reliably produce visual phosphenes or spots of light without any significant adverse events. This important milestone provides early safety and performance data for stimulation of the visual. These results will be used to inform the ongoing development of the Orion I Visual Cortical Prosthesis and to support the upcoming IDE submission to the US Food and Drug Administration. Importantly, the Orion I has a potential to restore useful vision to patients who are completely blinded from nearly any cost such as glaucoma, cancer, diabetic retinopathy or trauma. For these individuals who currently have no therapeutic option, the Orion I offers hope and the chance to gain independent and prove their quality of life. In addition to this very exciting news on the Orion I, we remain focussed on enhancements to the Argus II with the goal of improving the patient experience. We started patient testing with new retina stimulation techniques with the expectation of improving the quality of vision achieved and the initial results are promising. At the same time we are actively developing our next generation externals and next generation image processing software. This new system will be able to support the new retinal stimulation techniques that we're currently testing on patients. Turning to our Age-Related Macular Degeneration (NASDAQ

[Tom Miller:]

Thanks, Bob. For the third quarter of 2016, net sales were $1.2 million compared to $2.2 million in the third quarter of 2015. The decrease in revenue was driven by three primary factors. First, the reduced US CMS reimbursement rate for 2016. Second, the timing of revenue recognition due to certain deal terms which increase the amount of revenue recognised in the third quarter of 2015. And third, the geographic mix of implants which favoured AMEA in the current year where we historically have received a lower level of revenue per implant. Given this, the average revenue per implant were $84,000 in the third quarter of 2016 compared to a $148,000 in the third quarter of 2015. With the increase in the CMS reimbursement rate for 2017, we expect that our average revenue per implant will be in the range of $100,000 and $120,000 in fiscal 2017. Depending on the geographic mix of implants, we generated a gross loss of $1.4 million in the quarter compared to a gross profit of $1.5 million in the third quarter of the prior year. The cost of sales for the third quarter includes approximately $700,000 of unabsorbed manufacturing cost due to a lower production volume and a $1 million charge for excess inventory. As discussed on the call last quarter, we had taken certain steps to reduce our manufacturing production and we'll continue to monitor our inventory levels. At the appropriate time, we will resume normal production of Argus II implants. Until then, we expect to continue to generate gross losses and unabsorbed manufacturing over ahead. We still believe that the Argus II can generate solid positive gross margin a sales ramp in future periods. R&D cost, net implant revenues were $1.6 million at the current year third quarter compared to $593,000 in the prior year quarter. More than half of these costs were related to the application of resources for manufacturing to R&D and the remaining increase related to higher new spending on the Orion Cortical Project in development of next generation externals. I would like to remind listeners that starting next year because on the expiring grant, we could have less grant revenue if our new grant applications are not approved to offset our R&D expense. Clinical and regulatory cause decrease to $609,000 compared to $984,000 do impart to lower new patient enrolment and post market clinical trials in lower levels of compensation expense. We expect clinical expense to increase in 2017 as we begin clinical trials for the Orion Cortical Prosthesis at our next generation externals. Selling general and administrative cost increased approximately $300,000 of 7% for $4.6 million in the third quarter of 2015 to $4.9 million of the third quarter of 2016. Approximately a $110,000 of this increase is related to higher stock based compensation cost in the current year, excluding these non-cash cost. SG&A increased by 5% in the third quarter of 2016 compared to the third quarter a year ago, mainly related to customer outreach programs in general corporate expenses such as insurance. Our net loss for the third quarter of 2016 was $8.5 million or $0.20 per share. This compares to a net loss of $4.7 million or a $0.13 per share for the third quarter of 2015. We reported non-cash charges for $2 million during the third quarter consisting of stock based compensation of $964,000 and a $1 million reserve for excess inventory. This compares to non-cash charges of $943,000 in the third quarter of 2015 which was all for stock based compensation. Excluding these non-cash charges, our non-GAAP net loss for the third quarter of 2016 was $0.15 per share compared to a non-GAAP net loss of $0.10 per share in the third quarter of 2015. A full reconciliation of our GAAP net loss to a non-GAAP net loss including a per share reconciliation can be found in the tables at the end of our earnings release. Moving to the balance sheet, as of September 30, 2016, we had $17.8 million of cash in money market funds with no debt. Based on our current sales and expense projections, we believe that this is sufficient cash to fund our business for at least through the second quarter of 2017. With that, I'll turn the call over to Will.

[Will McGuire:]

Thanks, Tom. As Bob provided in his opening remarks, the third quarter was an exciting period for our company. I'd like to review in more detail some of the positive developments. Let's begin with reimbursement. First, CMS posted the 2017 Medicare hospital outpatient payment rates yesterday. The Medicare hospital outpatient payment rate for the Argus II device and procedure will be a $150,000 as of January 1 2017. Second, we are pleased that the AMA has approved our application for two new Category III CPT Codes for initial programming and reprogramming of the Argus II. This decision is significant as it will enable commissions to build for these critical activities. Third, we continue to make progress with our efforts to secure reimbursement in England through a new commissioning through evaluation our CTE program. National Health Service or NHS England recently requested further information from us and visited one of our implanting centres to spend time with an Argus II patient. While the details and timetable for the final determination are still being worked out, we continue to be encouraged by the progress in the UK and we'll keep you updated. Finally, we have also taken our first steps to pursue a reimbursement in Belgium and submitted a request for reimbursement to the National Authority. Turning now to our commercial performance. As noted earlier, global implant volume grew to 14 in Q3 from a 11 in Q2. The total implants outside of North America was 10. We continued to make progress in obtaining regulatory approvals in Iran, Taiwan, South Korea, and Argentina. We have begun training for our new distributor partners and will be supporting their efforts to apply for funding and reimbursement. While the timing for each market is somewhat difficult to project, we remain confident that these indirect markets will provide meaningful growth opportunities for Second Sight in the coming years. One final note concerning our European business. Competitors continued to conduct clinical trials in Europe and we suspect that we have lost some patients to these trials. Turning to the U.S. and Canada, our volume remained steady at four units as we noted last quarter we are in the process of revising our U.S. strategy with a focus on creating Centers of Excellence. While I am pleased with the progress we are making on that front it will take some time for these changes to be reflected in the implant numbers. The U.S. marketplace is in a period of transition. Let me provide some context. During 2014 and 2015 most customers were very excited to perform one or two Argus II procedures. This represented an important advancement in-line with their mission as well as the valuable public relation story. Many accounts experienced challenges as they became aware of the new activities required for this destructive technology. They struggled to get full reimburse for the advice and procedure, – they struggled to get fully reimbursed for the advice and procedural costs since obtaining fully reimbursement was not a straightforward in 2014 and 2015 as it is now. As a result many chose to put on-hold additional patients well into this year until they have fully reconciled reimbursement for their initial patients, the process that took considerable time and effort. The post surgery programming was also time consuming and there were no CPT codes to report and build those services. And finally, the post surgery rehabilitation infrastructure was variable across our accounts. We believe patients participating in a rehabilitation program will have better outcomes than patients that do not. Our best centers have made clear the path to higher or consistent patient volume. Number one, address the cost associated with effectively managing their patients. And number two, help them with better more consistent patient outcomes particularly in the area post surgery rehabilitation. Our centers of excellence strategy is designed to address these issues and build stronger better equipped partners. The strategy consists of four major initiatives; financial, patient recruitment and screening, post-surgery programming and lastly patient support and artificial vision rehab. Let me take you through each one. First, there are the financial considerations. As noted few times the CMS final rule assigned a Medicare hospital outpatient payment rate of 150,000 for the Argus II and the related procedure. We intend to deploy pricing strategy that enables our customers to be adequately compensated for their cost of providing the service. We are also pleased that effective July 1, 2017 CPT codes for post-surgery programming will be available. These developments combined with continued reimbursement for physicians, professional services and in-clinic rehab should eliminate concerns regarding the economics of an Argus program. In terms of patient recruitment and screening, we will focus our outreach efforts around select centers to ensure a steady flow of patients. We have also improved the way that we screen perspective patients so that individuals who are referred to hospitals have a higher probability of being a candidate for surgery. Finally, we have a significant number of eligible motivated patients that don't currently have access to Argus because they must travel 100 of miles to a center for screening, for surgery and for post-surgery programming and rehabilitation. We are activating plans with the few of our most experienced centers to provide highly qualified treatment for these patients. In terms of the post-surgery programming, our recent and future product improvements for aimed at improving the programming experience for the clinicians and for the patients as with the surgery repetition will make the programming more routine for the clinician and as mentioned earlier we have secured CPT codes to allow clinicians to submit for reimbursement when they program an Argus device. The last color of this initiative patient support and artificial vision rehab is extremely important. We have been working with various sites to identify and document best practices related to rehab with the goal of being an improved comprehensive rehab guide. Our new rehabilitation program will include certification level training with the plan of providing valuable CE use, our continuing education units to our dedicated customers. From here we collaborate with our customers so that our patients go through this rehab curriculum with particular attention to the important first three to four months post surgery. In summary the aim of this program is to establish implanting centers and physician clinics that are more intimately knowledgeable, self sufficient and confident enabling them to able to treat a higher volume of patients. On the R&D front, opt as to many of the key accomplishment from the past 90 days. The successful implantation and activation of wireless visual cortical stimulator in the first human subject is obviously the highlight. This human proof of concept study supports our ongoing efforts to develop the Orion 1 and moves us closer to achieving our goal of treating all forms of blindness. As stated in our press release we still have a lot of work ahead of us but our confidence in and excitement for the Orion technology has grown stronger. Our goal remains to start human feasibility trail with our Orion technology in the first half of 2017. We also continued to make significance progress with enhancement to our Argus II technology. Increasing the satisfaction of Argus II patients and improving the quality and usefulness of artificial vision is the high priority for us. As Bob mentioned we have started patient testing of new retinal stimulation techniques with the goal of improving resolution and increasing the brightness of [pulse], we are also making progress with the development of our next generation externals and exploring image processing advances including enhanced definition of objects, facial detection and depth information. In fact we recently received two research grants totaling more than $450,000 from the National Eye Institute to complete image processing research with retinal implants. Commercial roll outs of these exciting software enhancements on the new platform will depend on outcome from testing and additional regulatory approvals. We had originally targeted the end of this year for filing our -- for regulatory filing for our next generation externals but now expect the filing to occur in mid 2017. We have reallocated resources to conduct increased clinical work with retinal stimulation techniques and image processing. Ultimately we expect this work to lead to better vision for our patients and provide the opportunity to expand our market into better sighted individuals. We strongly believe this focus is appropriate and our effort to deliver the most benefit to the greatest number of patients. We continue to track the AMD patients enrolled in our feasibility trail in Manchester. In these cases, the patients are able to integrate their native peripheral vision with their artificial central vision and patient's report that they enjoy using their Argus system. As Bob mentioned we are currently preparing a revised protocol for submission. Once the protocol is approved we will move forward with treating additional patients. Finally, I want to take this opportunity to thank the hard working employees of Second Sight and to emphasize how encouraged I am by the progress we have made in all areas of the company. With that I would like to open the call for questions. Operator, please go ahead with the instructions.

[Operator:]

Thank you, sir. [Operator Instructions] Our first question comes from the line of Dallas Salazar with Atlas Consulting, your line is open. Please go ahead.

[Dallas Salazar:]

Hi guys, nice quarter. It sounds like you made some good progress. Thanks for taking Q&A. I just had two quick ones, the short but meaningful. My first question is, can you explain the status of the long term investor ride?

[Tom Miller:]

Yes, I can do that. This is Tom. In a very timely question the long term investor ride or LTIR matures on November 24, the end of this month which is the two year anniversary of the IPO closing day. We issued with every share in the IPO and LTIR, now to qualify for the LTIR investors will require to hold the shares in their name and certificate form and not a street name during the 24 month period following the IPO. Now [Audio Gap]

[Dallas Salazar:]

Yes I appreciate that. I think that's helpful in risk managing, so thank you. The second question would be can you just give us, investors any more information on the status of the plans for AMD?

[Dr. Robert Greenberg:]

Sure, Dallas this is Bob, I will take that. So, let me give maybe a little bit of background to kind of where we stand on the current clinical trial and then kind of lead to where we heading with it. So, as you may recall we implanted five patients in the U.K. and these patients are doing well, they report being able to see the outlines of other people heads. They can integrate their native and artificial vision. This is one of the questions that we had going into the trial. They report liking the system and using it to watch TV and garden. And importantly their native vision appears to be preserved which is another question because using AMD patients unlike the RP patients still have some residual vision. So we wanted to make sure we aren't harming that. We still need to demonstrate a real world impact and optimize the rehab to ensure that payers will reimburse for the system with patients with AMD. In addition, we did see some adverse events, so the adverse events were successfully managed by the physicians and so not unexpected in the first few cases of any new indication. So our plan going forward is we will be applying to the U.K. authorities to make some protocol changes to reduce the adverse event rates and also to improve the performance. We are working on some protocol changes that will allow us to test some of the image processing techniques and new retinal stimulation strategies that we can test new patients as well as we are working on some new versions of the implant that would be dedicated for AMD. But our plan is next year to begin soon we get an approval from the regulatory authorities to begin implanting more patients. We haven't yet solidified on a number of patients but we are encouraged by these early first five patients and we are looking forward to testing more patients to demonstrate not only the improved efficacy, but also the improved safety that we expect to see going forward before expanding to an even larger trial for market approval.

[Dallas Salazar:]

Yes. Thank you. Thanks again for the comprehensive answer. And even I have been telling the story in Chinese back and forth since the IPO days. So appreciate you always being there for comprehensive answers and in taking the sub-questions. Thank you guys.

[Dr. Robert Greenberg:]

Thank you.

[Operator:]

And our next question comes from the line of Jim Collins with Portfolio Guru, your line is open. Please go ahead.

[Jim Collins:]

Yes just hoping that you could expand on the last bullet point in the press release, you signed an exclusive rights into funding agreement etcetera, can you just talk about who the commercial partner is, what type of company anyway and what is the scope and magnitude of that funding agreement?

[Dr. Robert Greenberg:]

Yes. So I will take that. It's Bob again. Thanks for the question Jim. So we are not announcing the name of the company but it's a small company. It's a small technology based company that had some unique image processing technology that we had done some work with and it showed promising results in patients. Patients were able to perform some task that they couldn't without this new image processing technology and so we entered into kind of a twofold agreement with them. One was we – one was the exclusive license for the technology to apply it to vision prosthetics but and then the second was the applied with them for some grants. And so, we were fortunate that to get $450,000 worth of grants from the National Eye Institute and they were able to get some additional grant funding as well. So going forward we will continue to work with them to perfect that technology and implement it in our next generation external. So this will be software in one case, a hardware modification to the external system that in initial testing at Johns Hopkins it looks like it's performing, improving the quality of patient's vision.

[Jim Collins:]

Okay and the back to, I think I sort of missed what Tom said about what you are doing to manage inventory now so I guess the question is if I watch your facility today what sort of production rate are you adding and when this echo back to normal?

[Tom Miller:]

Well, most of our R&D, our manufacturing efforts right now are going to support R&D efforts and so we are not really making more Argus II at the moment. We are looking at the inventory levels and when we see a rebound in implants, when we see that going up, we will make a decision about increasing production. So right now we did reduce a lot of our manufacturing staff. In the second quarter of the year we kept some key people on board and we are using them once again to support some of our R&D efforts on the cortical and on the new externals. So you would not see a whole lot of, well you won’t see any activity on the Argus. You would see activity on some of our prototype development.

[Jim Collins:]

And then for 2017, obviously I think we are all expecting that the implantation rate will snap back as the reimbursement rate goes back to 150,000 so at what point would you need to start running the line again or to use that industrial phrase and how quickly can you get things restarted to scale Argus II production?

[Will McGuire:]

Yes this is Will. I mean, we really haven't given forecast or anything concerning implants next year. We do expect the rate to increase next year. A couple of things would drive that in the U.S. it's the implantation of our Centers of Excellence program and specifically some of the things we talked about in the call focusing our efforts to recruit patients by improving and now reimbursing the program in post-surgery and then finally maybe most importantly improvements that we are making to the post-surgery rehab. So that there will address some of our current accounts as well as some of the new accounts as they come on board and put them in a position we think to start doing higher consistent volume. The second thing that will drive increased volume is the kind of resumption in the U.S. if you will, adding new accounts. We haven’t added too many new accounts in the U.S. in the last 12 to 14 months and we are in pretty active discussions with quite a few accounts now. And I think you should expect to see us adding new accounts in 2017 on a regular basis. And finally, kind of the third piece that could drive the volume would be MAC expansion. So getting additional MACs to issue a positive recovery decision, outside of the U.S., we expect growth there as well. There the growth will be driven, the two opportunities I think for growth outside of the U.S. would be number one getting a positive reimburse decision for UK or for England, and then the opening up of some of the distributor markets that I talked about during the call. And then based upon that we really just have to track, I don't think Tom has very specific answer. We will track our remaining Argus II inventory and at some point we will have a trigger that if we get down to low enough inventory we will resume production. When we did scale back our production activities last quarter or the quarter before we were very cautious and the people that we retained and the people that we have in place now being the ones that we think are the most skilled and the most critical for restarting production and ramping back up in a consistent manner. So I think we did a nice job of thinking through that and we feel very comfortable that we have the ability to ramp up in ample time to meet any demand we would see in the near future. It will be little more than you asked for that Jim.

[Jim Collins:]

No, thanks. I appreciate the color Will, and last question I promise, but Tom mentioned having enough cash to make it through the second quarter of 2017, I guess the question is what happens next especially given that your stock is trading at, basically an all time well. So what do you sort of considering as far as this capital raising option for next year?

[Tom Miller:]

Well, we think that we have a lot of financing options. I don't want to go through all the things we talk to people about but we are on ongoing discussion with our board and ultimately it's going to be their call. But just like this year we had a very successful rates offering in June and we are in discussions with our board about various opportunities and options and we will make the call before we – sometime when we are thinking the first quarter, second quarter, at the latest we would do something.

[Will McGuire:]

Yes, this is Will. I will just add. I think we probably need to make a decision sometime in Q1. We obviously would rather be sitting here to much higher stock price everything looks better from a potential equity raise standpoint, but we are confident that we will have several options available to us. And we are confident that funds will be available. We just make that decision a little later this year or early next year and of course when we make a decision we will inform you guys about our plans.

[Jim Collins:]

Okay, great, thanks Will, thanks Bob and thanks Tom.

[Will McGuire:]

You are welcome.

[Operator:]

And there are no further questions on the phone lines. I will now turn the call back to the presenters. You may continue with your presentation or closing remarks.

[Will McGuire:]

Thank you all for joining us today, we are especially grateful to our shareholders who support our goal of making the dream of sight, the reality for blind individuals around the world. Have a great day.

[Operator:]

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