Vivani Medical(VANI)

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Vivani Medical(VANI) - 2021 Q1 - Quarterly Report
2021-05-12 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, DC 20549 FORM 10-Q (Mark One) ☐ 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 jurisdiction of incorporation or organization) California 02-0692322 (I.R.S. Employer Identification No.) ☒ QUARTERLY REPORT PURSUANT TO S ...
Vivani Medical(VANI) - 2020 Q4 - Annual Report
2021-03-15 16:00
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, 2020 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) - 2020 Q3 - Quarterly Report
2020-11-12 22:01
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, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ________ to ________ (Exact name of Registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) California 02-06 ...
Vivani Medical(VANI) - 2020 Q2 - Quarterly Report
2020-08-13 20:10
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, 2020 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 ...
Vivani Medical(VANI) - 2020 Q1 - Quarterly Report
2020-06-26 20:56
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, 2020 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) - 2019 Q4 - Earnings Call Transcript
2020-03-19 22:51
Second Sight Medical Products, Inc. (EYES) Q4 2019 Earnings Conference Call March 19, 2020 4:30 PM ET Company Participants Lisa Wilson – Investor Relations Will McGuire – President and Chief Executive Officer Pat Ryan – Chief Operating Officer John Blake – Chief Financial Officer Conference Call Participants Amit Dayal – H.C. Wainwright Kyle Bauser – Dougherty & Company Operator Thank you, ladies and gentlemen, for standing by and welcome to today's program entitled, Second Sight Medical Products’ Fourth Qu ...
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
PART I FINANCIAL INFORMATION [Financial Statements](index=3&type=section&id=Item%201.%20Financial%20Statements) The unaudited condensed consolidated financial statements show increased cash and equity from a rights offering despite declining sales and operating losses, with substantial doubt about going concern - The company has incurred recurring operating losses and negative cash flows since inception and has **substantial doubt about its ability to continue as a going concern**. It does not have sufficient funds to support operations for the next 12 months[34](index=34&type=chunk)[35](index=35&type=chunk) - In May 2019, the company accelerated its transition to the Orion platform and suspended Argus II production, resulting in a **$2.6 million inventory impairment charge** and **$0.7 million in restructuring charges** for severance and termination benefits in the first nine months of 2019[37](index=37&type=chunk)[110](index=110&type=chunk) Condensed Consolidated Balance Sheet Highlights (in thousands) | Account | September 30, 2019 | December 31, 2018 | Change | | :--- | :--- | :--- | :--- | | Cash and cash equivalents | $18,462 | $4,471 | +312.9% | | Total current assets | $20,356 | $9,620 | +111.6% | | Total assets | $23,898 | $10,682 | +123.7% | | Total liabilities | $9,612 | $7,598 | +26.5% | | Total stockholders' equity | $14,286 | $3,084 | +363.2% | Condensed Consolidated Statements of Operations Highlights (in thousands, except per share data) | Metric | Q3 2019 | Q3 2018 | 9 Months 2019 | 9 Months 2018 | | :--- | :--- | :--- | :--- | :--- | | Net sales | $472 | $2,246 | $2,882 | $5,129 | | Gross profit | $108 | $462 | $854 | $1,842 | | Loss from operations | $(7,619) | $(8,546) | $(25,828) | $(26,303) | | Net loss | $(7,584) | $(8,522) | $(25,724) | $(26,236) | | Net loss per share | $(0.06) | $(0.12) | $(0.22) | $(0.41) | [Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the strategic pivot to the Orion platform, resulting in declining revenue, restructuring charges, increased R&D, and ongoing liquidity challenges despite a rights offering - The company is shifting focus from the Argus II, with a **limited addressable market of approximately 1,500 patients** in the US, to the Orion system, which could **potentially treat 50,000 to 100,000 individuals** in the US who are blind from various causes[84](index=84&type=chunk)[100](index=100&type=chunk) - An early feasibility study of Orion in six subjects showed a **good safety profile and encouraging efficacy data**. The FDA granted Orion the **Breakthrough Devices Program designation**, which may expedite its development and review[82](index=82&type=chunk)[102](index=102&type=chunk) - The company does **not have sufficient funds to operate for the next 12 months** and will need to **seek additional capital** through financing, grants, or partnerships; failure to obtain funding could require **significant curtailment of operations**[95](index=95&type=chunk)[135](index=135&type=chunk)[137](index=137&type=chunk) - In February 2019, a rights offering provided **net cash proceeds of approximately $34.4 million**, significantly boosting liquidity, with entities controlled by the Chairman of the Board **investing approximately $30 million** in the offering[93](index=93&type=chunk)[136](index=136&type=chunk) Comparison of Operations - Q3 2019 vs Q3 2018 (in millions) | Metric | Q3 2019 | Q3 2018 | Change | Reason | | :--- | :--- | :--- | :--- | :--- | | Net Sales | $0.5 | $2.2 | -79% | Decrease in Argus II implants (4 vs 20) due to strategic shift | | Selling & Marketing Exp. | $1.3 | $3.0 | -57% | Reduced commercial activities for Argus II | | R&D Expense | $3.4 | $2.7 | +26% | Increased investment in Orion platform development | [Quantitative and Qualitative Disclosures About Market Risk](index=33&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) The company's primary market risks are interest rate sensitivity on cash investments and foreign currency fluctuations, with 37% of revenue in Euros and no hedging - The company's investments consist solely of money market funds, exposing it to **interest rate risk**[146](index=146&type=chunk) - Approximately **37% of revenue** for the first nine months of 2019 was **denominated in Euros**, creating **foreign exchange rate risk**, and the company has **not entered into foreign currency forward contracts to hedge this exposure**[147](index=147&type=chunk) [Controls and Procedures](index=33&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of September 30, 2019, with no material changes in internal control over financial reporting - Based on an evaluation as of September 30, 2019, the CEO and CFO concluded that the company's disclosure controls and procedures were **effective at a reasonable assurance level**[148](index=148&type=chunk) - **No changes in internal control over financial reporting occurred** during the quarter ended September 30, 2019, that materially affected, or are reasonably likely to materially affect, internal controls[149](index=149&type=chunk) PART II OTHER INFORMATION [Legal Proceedings](index=34&type=section&id=Item%201.%20Legal%20Proceedings) The company faces 22 patent opposition challenges in Europe and settled an advertising dispute, with management not expecting a material impact on operations - The company is defending against **22 oppositions** filed by third parties in the **European Patent Office** **challenging the validity of its European patents**[153](index=153&type=chunk) - On August 22, 2019, the company concluded a **settlement agreement with Pixium Vision SA**, **resolving all advertising disputes** between them[154](index=154&type=chunk) [Risk Factors](index=34&type=section&id=Item%201A.%20Risk%20Factors) This section highlights significant risks, including the Argus II to Orion transition, dependence on Orion's success, potential adverse clinical events, stricter EU regulations, and Nasdaq delisting risk - The strategic transition from Argus II to the Orion platform will result in **material near-term losses**, **market uncertainty**, and could **adversely affect remaining Argus II sales**[156](index=156&type=chunk)[157](index=157&type=chunk) - The company's future success is **highly dependent on the development, regulatory approval, and commercialization of the Orion product**, which is **not guaranteed**[158](index=158&type=chunk)[159](index=159&type=chunk) - Orion clinical trials have shown **potential adverse events**, including a **seizure in one subject** and **electrode impedance issues in two others**, which could **delay or halt development and regulatory approval**[168](index=168&type=chunk)[169](index=169&type=chunk)[170](index=170&type=chunk) - The company faces a risk of its common stock being **delisted from Nasdaq** for **failing to maintain the minimum $1.00 bid price requirement**, with a **compliance deadline of January 20, 2020**[174](index=174&type=chunk) [Unregistered Sales of Equity Securities and Use of Proceeds](index=40&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred during the period - None[186](index=186&type=chunk) [Defaults Upon Senior Securities](index=40&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) No defaults upon senior securities occurred during the period - None[186](index=186&type=chunk) [Mine Safety Disclosures](index=40&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[187](index=187&type=chunk) [Other Information](index=40&type=section&id=Item%205.%20Other%20Information) No other information to report for the period - None[188](index=188&type=chunk) [Exhibits](index=41&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with Form 10-Q, including officer certifications and XBRL data files - The report includes **certifications from the Principal Executive Officer and Principal Financial Officer** as required by **Sections 302 and 906 of the Sarbanes-Oxley Act**[191](index=191&type=chunk) [Signatures](index=42&type=section&id=SIGNATURES)
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 ...