Earnings Labs

Vivani Medical, Inc. (VANI)

Q3 2017 Earnings Call· Mon, Nov 6, 2017

$1.37

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Transcript

Operator

Operator

Ladies and gentlemen, thank you for standing by. Welcome to the Second Sight Q3 Results Call. [Operator Instructions]. As a reminder, this conference is being recorded, Thursday, November 2st, 2017. I would now like to turn the conference over to Lisa Wilson, Investor Relations. Please go ahead ma'am.

Lisa Wilson

Analyst

Thank you, Kai. Good afternoon and welcome to Second Sight's third quarter 2017 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. At the close of market, the company issued a press release detailing financial results for the three and nine months ended September 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 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 November 02, 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 our call this afternoon. I am very pleased to report that we continue to make good progress towards achieving our three key goals. First to validate our recently implemented centers of excellence commercial model, our success will be measured by increasing the number of senators performing at least one new implant on average per quarter. Second, to demonstrate our ability to treat better sighted individual's success there will be measured by clinical testing in humans which will give us confidence that we will be able to expand our addressable market. Finally, to implant the first Orion patient this year. With respect to our clinical and R&D progress to-date we continue to make significant strides. Our better sided RP initiatives remain on track. The better side at RP clinical study will begin shortly in Germany and we plan to pursue a similar expanded indication with the U.S. FDA in 2018. We received conditional approval for the Orion feasibility study in August and this was moved to full approval as we announced earlier today. We anticipate implanting the first subject for the feasibility this year. We also submitted an application to the FDA to request that Orion receive official designation as a breakthrough device, with this designation Orion would be eligible for priority review and potentially allow us to get to market faster and at a lower cost. We continue to strengthen our management team as well with the appointment of Frank Vandeputte as VP and General Manager of our Europe and Asia Pacific regions and the transition of Gregoire Cosendai to his new role as VP of Clinical Affairs. Their depth of experience will be invaluable as we continue to build upon the momentum of the business. With that I'd like to now turn the call over to Tom to review our third quarter financial results. Tom?

Tom Miller

Analyst

Thank you, Bob. For the third quarter of 2017 net sales were $1.6 million compared to $1.2 million in the third quarter of 2016. The company received higher revenue per implant due to the higher CMS reimbursement rates in 2017 and the collection of some deferred revenue. Our implant volume declined to 12 units compared to 19 during the immediately preceding second quarter of 2017 and 14 implants during the prior year quarter. This is largely due to decline in our European markets where we have historically seen a dip in implant volume during the summer months due to the difficulty in scheduling elective procedures during the European holidays. The average revenue per implant was $134,000 in the third quarter of 2017 compared to 84,000 in the third quarter of 2016 reflecting the benefit of higher CMS pricing, the higher mix of U.S. implants and the collection of $361,000 of deferred revenue. During the quarter seven implants were performed in North America compared to four during the same quarter of 2016. In Europe, the Middle East and Asia implant volume declined to five units compared to 10 in the prior year quarter. We generated a gross profit of $609,000 in the quarter compared to a gross loss of $1.4 million in the third quarter of 2016. Gross profit in the third quarter of 2017 included a credit of $275,000 to partially reverse a previously established reserve for slow moving inventory as we continue to work down the balance of excess inventory units. The gross loss for the third quarter of 2016 included a reserve for slow moving inventory of $1 million. R&D costs including the offset due to grant revenue were $1.8 million during the third quarter of 2017 compared to $1.6 million in the prior year quarter, this 15%…

Will McGuire

Analyst

Thanks, Tom. I'd like to begin with the changes to our management team. The team has become considerably stronger and we're positioned for a great close to 2017 and even stronger 2018. First Frank Vandeputte, a highly experienced commercial leader has been appointed VP and General Manager of our European and Asia Pacific operations. He has a three-decade long track record of launching innovative technologies and building new businesses. Frank will access our strategy in both direct and indirect markets and make the needed changes to ensure we're driving adoption and creating global centers of excellence. Next Gregoire Cosendai, formerly VP of European Operations has assumed the role of VP of Clinical Affairs. He will lead Second Sight's clinical efforts focusing on our market expanding trials with Orion and Better Sighted RP subjects. His first priorities will be the initiation of the Orion feasibility trial as well as the initiation of our Better Sighted RP patient trial in Germany. I will now like to turn to our 2017 corporate goals. As Bob mentioned we are making great progress against all of our stated goals. First, we are getting traction with our centers of excellence model in North America and are seeing an increasing number of centers perform Argus cases on a regular schedule. Second our testing of innovative retina stimulation programs is proceeding with encouraging results and we are preparing to begin the German trial for Better Sighted RP patients. Finally, the company continues to execute against all R&D clinical and regulatory goals related to the Orion program and we're prepared to implant our first human subjects by the end of this year. Our goals are ambitious but with focus and execution we remain on track and expect to achieve them. Let's now dive into a little more detail on…

Operator

Operator

[Operator Instructions]. And there are no questions at this time.

Robert Greenberg

Analyst

Thank you again to our investors for their continued support and thanks to everyone for their participation on our call today. 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.