Vivani Medical(VANI)2019-08-07 00:46Financial Data and Key Metrics Changes - Net sales for Q2 2019 were 1.9 million in Q2 2018, with revenue recognized for ten implants at an average selling price of 112,000 in the same period last year [42][43] - Research and development expenses net of grants increased to 2.4 million in Q2 2018, reflecting additional headcount and costs for prototypes [43] - Selling and marketing expenses decreased to 2.9 million in Q2 2018, expected to decline further as Argus II commercial activities are reduced [46] Business Line Data and Key Metrics Changes - Eleven Argus II devices were implanted in Q2 2019, with seven in the U.S. and four outside the U.S., indicating a shift in focus towards the Orion platform [38] - The company expects net sales to decline as it sells through existing inventory of Argus II devices [43] Market Data and Key Metrics Changes - The Centers for Medicare & Medicaid Services (CMS) finalized a new payment pathway for innovative technologies with FDA breakthrough device designation, which is expected to improve patient access and reimbursement for Orion [30][32] - The average outpatient rate for the Argus II and associated surgical procedure remains at 152,500 for 2020, consistent with 2019 [37] Company Strategy and Development Direction - The company is focused on advancing the Orion platform, with significant progress in clinical and regulatory strategy, including a pre-submission to the FDA and positive feedback received [8][25] - Key objectives for the second half of 2019 include executing Orion R&D projects, finalizing FDA agreements, and developing a comprehensive reimbursement strategy [40] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the performance of Orion subjects in the early feasibility study, with positive safety and efficacy data reported [10][12] - The company anticipates increased research and development expenses as it accelerates the transition to the Orion platform and conducts additional clinical trials [44][45] Other Important Information - The company recorded a restructuring charge of 0.9 million in Q2 2019, related to severance and inventory impairment as it plans to suspend Argus II [47] - As of June 30, 2019, the company had cash and cash equivalents of 6.5 million for the quarter [48] Q&A Session Summary Question: What exactly are you discussing and negotiating with the FDA? - The company is working through specifics of the pivotal study, including efficacy and safety endpoints, validation needs, and post-market data collection requirements [53][54] Question: Do you have options you are considering regarding the two paths? - Discussions with the FDA have primarily focused on the PMA path, but the company has also started exploring the HDE followed by PMA option [58][59] Question: What are the next catalysts or steps to look for? - The next step involves responding to the FDA's written feedback and possibly requesting further meetings to clarify requirements [60][62] Question: How soon can patients experience the new features being developed? - Human testing for distance filtering technology is expected in the second half of the year, with thermal imaging and eye tracking testing starting by early next year [63][65] Question: Is the CMS ruling on reimbursement for breakthrough devices already in effect? - The ruling will take effect on October 1, 2019, which is expected to improve reimbursement pathways for Orion [66][67] Question: How big is the NIH grant and what is remaining? - The company expects to receive approximately 5 million in additional funding, subject to annual approval [68]