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Vivani Medical, Inc. (VANI)

Q2 2017 Earnings Call· Wed, Aug 2, 2017

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Second Sight Q2 2017 Results Conference 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, Tuesday, August 1st, 2017. I will now turn the conference over to Lisa Wilson, Investor Relations. Please go ahead ma'am.

Lisa Wilson

Analyst

Thank you, George. Good afternoon and welcome to Second Sight’s second quarter 2017 earnings call. This is Lisa Wilson of Investor Relations for Second Sight. With me on today’s call are Dr. Robert Greenberg, Chairman of the Board; 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 six months ended June 30, 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’s 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 a 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 August 1, 2017. 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. Robert Greenberg.

Robert Greenberg

Analyst

Thank you, Lisa. And thank you all for joining the call this afternoon. We had a particularly strong second quarter and I'm excited to share the details with you. During the quarter, revenue was up sequentially and more than doubled year-over-year from $1.0 million to $2.2 million. We expanded reimbursement coverage with the addition of Novitas, the largest MAC in the U.S. This raises the total U.S. population living in covered states from a 120 million to over 200 million. The global reach of the Argus II also continues to grow. We expanded our footprint in Asia with two implants from South Korea and a second implant was completed in Taiwan where we just entered the market during the first quarter of this year. Additional implants were scheduled in these markets for later this year. And two weeks ago, we activated our first patient in Russia and will continue our efforts to develop this potentially significant market. In R&D, 14 Argus patients have been tested using a computer in a lab to assess the feasibility of advanced retinal stimulation techniques. Results so far are encouraging and we're now incorporating the most promising algorithms tested into the full Argus system and we will begin evaluating patient performance using these upgraded Argus systems later this year. Our test patient at UCLA with a wireless cortical stimulator continues to do well. And as a reminder, though this device is not the Orion, but a commercially available device that we use to collect initial human data and cortical stimulator provision. Also in mid-July, we submitted an Investigational Device Exemption application with the FDA to conduct a clinical feasibility study with the Orion Visual Cortical Prosthesis system with up to five blind human subjects. And we look forward to receive a response from the FDA and are very excited to reach this important milestone and believe this technology has the potential to dramatically increase our addressable market. We're encouraged by the momentum in the business and look forward to continue growth in Argus implants around the world. The total number of implants performed during the second quarter grew to 19 compared to 14 implants performed during the first quarter of this year. With expanded reimbursement coverage and new markets, we expect to see a continued growth in the business. Before I turn the call over to Tom to discuss the quarter's financials, I'd like to take a moment to thank Tom for all of his contributions to Second Sight. He was an integral part of our IPO process, pulling everything together on an incredibly short timeline. He has been a valued member of our management team and we wish him the best in his future endeavors. And as previously reported, Tom will stay on while we work through the transition. And with that, I'd now like to turn the call over to Tom Miller to review our second quarter results. Tom?

Tom Miller

Analyst

Hey, thank you, Bob. For the second quarter of 2017, net sales were $2.2 million compared to $1 million in the second quarter of 2016. Total implants increased to 19 during the second quarter, up from 14 implants during the prior quarter and 11 during the second quarter of 2016. The average revenue per implant was $118,000 in the second quarter of 2017 compared to $94,000 in the second quarter of 2016, reflecting the benefit of higher CMS pricing and volumes in the U.S. During the quarter, nine implants were performed in North America and 10 combined in Europe, the Middle East, and Asia. We generated a gross profit of $1.1 million in the quarter compared to a gross loss of $2.2 million in the second quarter of 2016. Goss profit in the second quarter of 2017 included a credit of $743,000 to partially reverse a previously established reserve for slow-moving inventory as implant volume rebounded. The gross loss for the second quarter of 2016 included a reserve for slow-moving inventory of $1.5 million. R&D costs including the offset due to grant revenue were $1.9 million during the second quarter of 2017 compared to $916,000 in the prior year quarter. This approximately $1 million increase was primarily due to higher spending on staffing and outside consultants related to new product development efforts and a decline of $682,000 in grant revenue due to a grant that was fully utilized by the end of first quarter of 2017. We expect that grant revenue and overall R&D cost will continue at approximately the second quarter spending levels for the remainder of the year. Clinical and regulatory costs were $684,000 during the second quarter of 2017 compared to $568,000 in the prior year quarter, primarily related to increase cost of preparing for the Orion…

Will McGuire

Analyst

Thank you, Tom. As you can see from our results, we've been focused on executing our business strategy and meeting our commitment. In the U.S., a revised Centers of Excellence strategy continues to gain traction. As a reference, in 2016, we had three accounts do two implants each in North America. These were our three highest volume accounts that year. During the first six months of 2017, we've had one account perform four implants, one account performed three implants, and one account performed two implants. This is exactly what we want to see as more accounts truly adopt Argus. As a reminder, our goal is that each Center of Excellence will be a high-quality surgical center that performs at least four implants per year, possesses the ability to do regular patient screening and surgery schedule, will provide accurate post-surgery programming, and is capable of managing the artificial vision rehabilitation process. We are now taking steps to aggressively expand our account base as we're confident that we have the understanding of resource requirements and expectations for a new center and as we have referenced with respect to expanded reimbursement and qualified patient candidates, we see account expansion as a primary execution lever to grow the business. Thus far, we have added two U.S. centers this year in Gainesville, Florida and most recently in Boston and remain on track with our 2017 goal of adding a total of five to 10 centers. The new center in Boston is significant because it's our first center in New England where already have Medicare coverage. Also the Northeast is a significant expansion opportunity for us going forward with a sizable target [Indiscernible] population. Regarding our patient database, we now have 65 patient candidates who have been telephonically screened by independent medical professionals; two-thirds of these…

Operator

Operator

[Operator Instructions] And our first question comes from the line of the Dallas Salazar with Atlas Consulting. Please go ahead with your question.

Dallas Salazar

Analyst

Hey guys. Great progress made during the quarter. Hope to see it continue. Can you go ahead and stack rank U.S. and OUS markets, just -- I guess the order of expected strength over the next 12 months?

Will McGuire

Analyst

Sure. Yes, I think we've touched on this in the past. I mean overall I expect our trend to be one of increasing implant volumes, but given some of the recent developments and given just the potential, the U.S. market definitely has the highest potential for growth and is a big focus for us. And I'd say a couple of drivers there Dallas, first, we have the potential for continued geographic expansion where we've had Medicare coverage, but no implanting centers. Boston is an example of that where we just opened up. New York is another place where we're focused on opening a center or two. We don't have a center New York City; we don't have one in Upstate New York. The recent Medicare coverage expansion by Novitas that opens up a lot of other geographic areas. So, in that entire area therewith 80 million people, we only have three centers right now. So, we'll definitely be adding centers there in places such as such as Texas and New Jersey. We also are making, as I reference, really good progress with our patient database in the U.S. and this patient data base continues to grow as well and in numbers, but it also continues to improve as far as the quality of patients. So, what this database will allow us to do is really to have a have a more consistent flow of qualified patients to our centers in the U.S. And then as I also mentioned the centers that we have that have been in place for some period of time that are in a covered MAC, we're going to see a number of those start planning on a more regular basis, which will drive volume. And then finally, I guess the last piece, we still have three MACs that have not made a coverage decision and we're hopeful that we'll get additional positive coverage decision from these MACs either this year or sometime next year, which just again, just increases the geographic areas for us to open centers and to treat Medicare patients. Outside the U.S., I probably don't see as much opportunity for growth in the next 12 months, but in the long-term, I do think the trend will be positive there. This year -- certainly the first half of this year, we've experienced some incremental growth from our indirect markets and we may see some continued upside from the indirect markets later this year. But overall, keep in mind, that our volume is relatively small and it's still possible to see some up and down movements with implant volume in any of these markets and we're not necessarily -- even though we expect to be growing, we're not necessarily immune to any seasonal fluctuations that any other medical device company would experience with a product that's used in elective case.

Dallas Salazar

Analyst

Sure. Thank you for that. And you actually answered one of my two other questions there, so appreciate the color. The last question that I would have is -- it’s a two-part. So, first, is the CMS 2018 proposed rate of $122,000 for the Argus II likely to change? And two, what was sort material are you submitting to have this increased?

Will McGuire

Analyst

Sure. Yes, I'll take that, this is Will. It could change, I mean it could go up or it could go down. As I stated, the current rate proposed is based upon three claims from 2016. We know there's more than three, something closer to six, seven, or eight additional claims that could be submitted and reviewed by CMS to make a final decision. Now, we've seen the majority of those claims and at this point, we don't think any of those claims would have a significant impact on the rate either up or down, but there's also one or two claims that we haven't seen dollars. So, not having seen those, it's hard to say if the data would drive the final rate up or down. But, again, we are working with our accounts as closely as possible to make sure that they are accurately and fully submitting data to CMS, so that CMS can make an appropriate decision. Now, as far as what we're doing, we have talked about in the past, we've lobbied that we'd like to see the rate remain unchanged from where it is right now. We think $150,000 is an appropriate rate that allows our customers to get sufficient reimbursement for the device and for the procedure and we'll continue to make our case with CMS. So, there's a period now -- that's a comment, so during this comment, we will provide our comments to CMS about what we think is appropriate as well as any alternate ways that they could approach rate-setting for 2018. And then we also expect that some of our customers and other industry trade groups will provide comments to CMS during that time period as well. So, I mean I guess bottom-line, we're hopeful that it remains at least where it's at now, but it's hard for us to give you any more color or put any probabilities on what the final rate will be. Hope that helps.

Dallas Salazar

Analyst

Yes. No, that solves it out. I can appreciate that. That's all that I had for you guys. Look forward to chatting in a couple of months. Thank you.

Will McGuire

Analyst

Great. Thank you.

Operator

Operator

[Operator Instructions] There are no further questions at this time. I'll now turn the call back to Will.

Will McGuire

Analyst

Great. Thank you. So, thanks to all of my coworkers at Second Sight for the hard work this year and thanks to our investors for their continued support. Have a great day.

Operator

Operator

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