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Vivani Medical(VANI) - 2019 Q4 - Annual Report
2020-03-19 20:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2019 For the transition period from ________ to ________ Commission File Number 001-36747 Second Sight Medical Products, Inc. (Exact name of Registrant as specified in its charter) California 02-0692322 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identificati ...
Vivani Medical(VANI) - 2019 Q3 - Earnings Call Transcript
2019-11-15 03:56
Second Sight Medical Products, Inc. (EYES) Q3 2019 Earnings Conference Call November 14, 2019 4:30 PM ET Company Participants Lisa Wilson - In-Site Communications, Investor Relations Will McGuire - President and Chief Executive Officer John Blake - Chief Financial Officer Conference Call Participants Amit Dayal - H.C. Wainwright Operator Greetings, and welcome to the Second Sight Third Quarter 2019 Results Call. During the presentation, all participants will be in a listen-only mode. Afterwards, we will con ...
Vivani Medical(VANI) - 2019 Q3 - Quarterly Report
2019-11-14 21:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number 001-36747 Second Sight Medical Products, Inc. (Exact name of Registrant as specified in its charter) (State or ...
Second Sight Medical Products (EYES) Presents At 2019 Wells Fargo Healthcare Conference - Slideshow
2019-09-05 19:04
SECONDSIGHT | --- | --- | --- | |----------------------------------------------------------|-------|-------| | | | | | Second Sight Medical Products, Inc. (NASDAQ: EYES) | | | | Discover Life in a New Light® | | | | | | | | 2019 Wells Fargo Healthcare Conference September 4, 2019 | | | Forward Looking Statements SECONDSIGHT The following slides and any accompanying oral presentation contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21 ...
Vivani Medical(VANI) - 2019 Q2 - Earnings Call Transcript
2019-08-07 00:46
Financial Data and Key Metrics Changes - Net sales for Q2 2019 were $1.3 million, down from $1.9 million in Q2 2018, with revenue recognized for ten implants at an average selling price of $128,000 compared to 17 devices at $112,000 in the same period last year [42][43] - Research and development expenses net of grants increased to $3.4 million in Q2 2019 from $2.4 million in Q2 2018, reflecting additional headcount and costs for prototypes [43] - Selling and marketing expenses decreased to $1.7 million in Q2 2019 from $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 $25.2 million, with a cash burn 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 $1.1 million for 2019 and is eligible for about $5 million in additional funding, subject to annual approval [68]
Vivani Medical(VANI) - 2019 Q2 - Quarterly Report
2019-08-06 21:01
OR UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2019 (Registrant's telephone number, including area code) 12744 San Fernando Road, Suite 400, Sylmar, CA 91342 (Address of principal executive of ices, including zip code) ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 (818) 833-5000 For the t ...
Vivani Medical(VANI) - 2019 Q1 - Earnings Call Transcript
2019-05-16 02:49
Second Sight Medical Products, Inc. (EYES) Q1 2019 Results Earnings Conference Call May 15, 2019 4:30 PM ET Company Participants Lisa Wilson - Investor Relations Jonathan McGuire - CEO, President John Blake - CFO & Corporate Secretary Conference Call Participants Sameer Joshi - H.C. Wainwright Kyle Bauser - Dougherty & Company Operator Greetings, and welcome to the Q1 2019 Results Call. During the presentation, all participants will be in a listen-only mode. Afterwards, we will conduct a question-and-answer ...
Vivani Medical(VANI) - 2019 Q1 - Quarterly Report
2019-05-15 20:31
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2019 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number 001-36747 Second Sight Medical Products, Inc. (Exact name of Registrant as specified in its charter) (State or othe ...
Vivani Medical(VANI) - 2018 Q4 - Annual Report
2019-03-19 01:59
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Fiscal Year Ended December 31, 2018 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ Commission File Number 001-36747 Second Sight Medical Products, Inc. (Exact name of Registrant as specified in its charter) (State or other juri ...
Vivani Medical(VANI) - 2018 Q4 - Earnings Call Transcript
2019-03-14 02:46
Second Sight Medical Products, Inc. (EYES) Q4 2018 Earnings Conference Call March 13, 2019 4:30 PM ET Company Participants Lisa Wilson - Investor Relations Will McGuire - President & Chief Executive Officer John Blake - Chief Financial Officer Conference Call Participants Andrew D'Silva - B. Riley Amit Dayal - H.C. Wainwright Jeb Terry - Aberdeen Investment Management Operator Ladies and gentlemen, thank you very much for standing by. And welcome to the Second Sight Q4 2018 Results Call. During the presenta ...