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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 ...
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 ...