Vivani Medical(US:VANI)2019-11-14 21:31PART I FINANCIAL INFORMATION Financial Statements 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 months3435 - 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 201937110 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 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 causes84100 - 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 review82102 - 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 operations95135137 - 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 offering93136 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 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 risk146 - 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 exposure147 Controls and Procedures 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 level148 - 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 controls149 PART II OTHER INFORMATION Legal Proceedings 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 patents153 - On August 22, 2019, the company concluded a settlement agreement with Pixium Vision SA, resolving all advertising disputes between them154 Risk Factors 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 sales156157 - The company's future success is highly dependent on the development, regulatory approval, and commercialization of the Orion product, which is not guaranteed158159 - 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 approval168169170 - 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, 2020174 Unregistered Sales of Equity Securities and Use of Proceeds No unregistered sales of equity securities occurred during the period - None186 Defaults Upon Senior Securities No defaults upon senior securities occurred during the period - None186 Mine Safety Disclosures This item is not applicable to the company - Not applicable187 Other Information No other information to report for the period - None188 Exhibits 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 Act191 Signatures