Vivani Medical, Inc.

Net sales were $0.5 million in Q4 2019 versus $1.8 million in Q4 2018. Revenue was recognized for three implants on a GAAP basis, with an average selling price of $166,000, compared with 16 devices at an ASP of $110,000 in the prior-year quarter. R&D expense, net of grants, was $4.1 million versus $2.4 million a year ago; clinical and regulatory expense was $1.0 million versus $1.2 million; selling and marketing expense was $1.0 million versus $2.4 million; and G&A was $2.3 million versus $2.5 million. As of December 31, 2019, cash and cash equivalents were $11.3 million, fourth-quarter cash burn was $7.1 million, and the company said it had runway into Q2 2020. For 2020, management said operating cash burn would be a little higher than the $27.6 million in 2019 due to heavier R&D and clinical work, but it did not provide revenue or EPS guidance.

Will McGuire framed the quarter around continued execution on Orion and a leadership transition. He said the company has made significant progress with R&D and FDA discussions, and emphasized that Orion’s clinical results and the new wearables approvals strengthen the path forward. His tone was upbeat but measured, stressing confidence in the team and saying he did not expect the organization to miss a beat under interim leadership.

John Blake focused on reimbursement, liquidity, and expense trends. He said the company had productive meetings with CMS, including discussion of national coverage for Orion, and noted outreach to private payers and lawmakers around breakthrough-device reimbursement. Financially, he highlighted the $11.3 million cash balance, $7.1 million fourth-quarter cash burn, and the expectation that 2020 operating cash burn will be slightly higher than 2019’s $27.6 million because of R&D and clinical spending; he also said G&A should remain flat going forward.

Analysts pressed on CEO succession, and management said the board is only in the early stages of the search, with Greg Williams serving as interim CEO. They also asked about FDA safety endpoints; management said the key unresolved issue is the acceptable serious adverse event rate for a first-in-class technology, plus related trial-size and post-market requirements, and expects alignment by the end of Q3. On timing, management said the IDE filing has shifted to the first half of 2021, not because of technical problems, but because of ongoing discussions with FDA; they also said COVID-19 has begun to complicate validation work and will delay some activities.