Eyenovia(US:EYEN)2021-05-13 16:00PART I - FINANCIAL INFORMATION Financial Statements This section presents Eyenovia, Inc.'s unaudited condensed financial statements for Q1 2021 and 2020, including key financial statements and explanatory notes Condensed Balance Sheets As of March 31, 2021, total assets decreased to $28.9 million from $33.9 million, driven by reduced cash, while liabilities and stockholders' equity also declined Condensed Balance Sheet Highlights (Unaudited) | Balance Sheet Item | March 31, 2021 | December 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $24,907,048 | $28,371,828 | | Total Current Assets | $28,025,208 | $33,391,345 | | Total Assets | $28,851,662 | $33,906,760 | | Total Current Liabilities | $16,365,616 | $18,198,377 | | Total Liabilities | $16,711,541 | $18,602,875 | | Total Stockholders' Equity | $12,140,121 | $15,303,885 | Condensed Statements of Operations For Q1 2021, Eyenovia recognized $2.0 million in license revenue, leading to a $1.2 million gross profit, while operating expenses increased, resulting in a net loss of $5.4 million, a slight improvement year-over-year Condensed Statements of Operations (Unaudited) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Revenue | $2,000,000 | $0 | | Gross Profit | $1,200,000 | $0 | | Research and development | $4,247,726 | $3,634,287 | | General and administrative | $2,300,327 | $1,836,782 | | Loss From Operations | ($5,348,053) | ($5,471,069) | | Net Loss | ($5,351,667) | ($5,450,910) | | Net Loss Per Share | ($0.21) | ($0.31) | Condensed Statements of Cash Flows Net cash used in operating activities improved to $4.6 million in Q1 2021, with financing activities providing $1.5 million, leading to a net cash decrease of $3.5 million and a quarter-end balance of $24.9 million Cash Flow Summary (Unaudited) | Cash Flow Activity | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net Cash Used In Operating Activities | ($4,573,846) | ($5,917,927) | | Net Cash Used In Investing Activities | ($344,320) | ($93,930) | | Net Cash Provided By Financing Activities | $1,453,386 | $5,515,347 | | Net Decrease in Cash | ($3,464,780) | ($496,510) | | Cash at End of Period | $24,907,048 | $13,656,091 | Notes to Unaudited Condensed Financial Statements These notes detail Eyenovia's operations, significant accounting policies, and disclose substantial doubt about its going concern ability, alongside specifics on license agreements and a subsequent $25 million loan agreement - The company has recurring net losses and cash outflows from operations, which raises substantial doubt about its ability to continue as a going concern for at least one year from the report's issuance date30 - In Q1 2021, the company recognized $2.0 million in revenue from the $4.0 million upfront payment received under the Arctic Vision License Agreement after submitting required trial data for MicroPine66 - The company received a $10.0 million upfront payment from the Bausch License Agreement, which was recorded as a deferred license fee and had not been recognized as revenue as of March 31, 202170 - Subsequent to the quarter end, on May 7, 2021, the company entered into a loan agreement with Silicon Valley Bank for up to $25.0 million, receiving an initial tranche of $7.5 million99 Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses the company's clinical-stage ophthalmic business, pipeline updates including MydCombi™ NDA acceptance, Q1 2021 financial results with increased expenses, and reiterates going concern doubt despite a new $25 million loan facility - The FDA accepted the New Drug Application (NDA) for MydCombi™, with an expected Prescription Drug User Fee Act (PDUFA) date of October 28, 2021110 - The company entered into significant license agreements with Bausch Health for MicroPine in the U.S. and Canada, and with Arctic Vision for MicroPine and MicroLine in Greater China and South Korea107109 Comparison of Operating Expenses (Q1 2021 vs Q1 2020) | Expense Category | Q1 2021 | Q1 2020 | Change | % Change | | :--- | :--- | :--- | :--- | :--- | | Research & Development | $4.2M | $3.6M | +$0.6M | +17% | | General & Administrative | $2.3M | $1.8M | +$0.5M | +25% | - As of March 31, 2021, the company had a cash balance of $24.9 million and an accumulated deficit of $82.8 million, with management noting substantial doubt about its ability to continue as a going concern125126 Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Eyenovia is not required to provide the information for this item - Smaller reporting companies such as Eyenovia are not required to provide the information required by this item135 Controls and Procedures Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2021, with no material changes to internal control over financial reporting during Q1 2021 - The principal executive officer and principal financial officer concluded that as of March 31, 2021, the company's disclosure controls and procedures were effective at a reasonable assurance level139140 - There were no changes in internal control over financial reporting during the first quarter of 2021 that materially affected, or are reasonably likely to materially affect, these controls141 PART II - OTHER INFORMATION Legal Proceedings The company reported no legal proceedings during the period - None145 Risk Factors As a smaller reporting company, Eyenovia is not required to provide the information for this item - Smaller reporting companies such as Eyenovia are not required to provide the information required by this item147 Unregistered Sales of Equity Securities and Use of Proceeds The company reported no unregistered sales of equity securities or use of proceeds from such sales during the period - There were no recent sales of unregistered securities149 Defaults Upon Senior Securities This item is not applicable to the company - Not applicable152 Mine Safety Disclosures This item is not applicable to the company - Not applicable154 Other Information The company reported no other information for this item - None156 Exhibits This section lists the exhibits filed with the Form 10-Q, including an executive employment agreement amendment, Sarbanes-Oxley certifications, and interactive data files - The exhibits filed with this report include certifications pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act of 2002 and interactive data files158