Eyenovia(EYEN) - 2021 Q3 - Quarterly Report

PART I - FINANCIAL INFORMATION This section presents Eyenovia, Inc.'s unaudited condensed financial statements and management's discussion for the period ended September 30, 2021 Item 1. Financial Statements. Eyenovia, Inc.'s unaudited condensed financial statements for Q3 2021, covering financial position, performance, and cash flows, are presented with detailed accounting notes Condensed Balance Sheets This section provides a snapshot of Eyenovia's financial position at September 30, 2021, and December 31, 2020 Condensed Balance Sheet Highlights (September 30, 2021 vs. December 31, 2020) | Metric | Sep 30, 2021 (Unaudited) | Dec 31, 2020 | | :-------------------------- | :----------------------- | :-------------------- | | Assets | | | | Cash and cash equivalents | $13,500,871 | $28,371,828 | | Restricted cash | $7,875,000 | — | | Total Current Assets | $23,459,340 | $33,391,345 | | Total Assets | $24,991,576 | $33,906,760 | | Liabilities | | |\ | Total Current Liabilities | $20,719,379 | $18,198,377 | | Total Liabilities | $20,745,438 | $18,602,875 | | Stockholders' Equity | | |\ | Total Stockholders' Equity | $4,246,138 | $15,303,885 | - Total assets decreased from $33.9 million at December 31, 2020, to $25.0 million at September 30, 2021, primarily due to a significant reduction in cash and cash equivalents, partially offset by an increase in restricted cash[13] - Total current liabilities increased by approximately $2.5 million, driven by a substantial increase in notes payable (current portion) from $97,539 to $7,282,037, indicating a shift in debt classification[13] Condensed Statements of Operations This section details Eyenovia's financial performance for the three and nine months ended September 30, 2021 and 2020 Condensed Statements of Operations Highlights (Three and Nine Months Ended September 30) | Metric (USD) | 3 Months Ended Sep 30, 2021 | 3 Months Ended Sep 30, 2020 | 9 Months Ended Sep 30, 2021 | 9 Months Ended Sep 30, 2020 | | :--------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Revenue | $— | $— | $4,000,000 | $— | | Gross Profit | $— | $— | $2,400,000 | $— | | Research and development | $3,470,188 | $3,363,759 | $11,334,296 | $9,913,296 | | General and administrative | $2,435,141 | $1,728,366 | $7,082,659 | $5,669,311 | | Total Operating Expenses | $5,905,329 | $5,092,125 | $18,416,955 | $15,582,607 | | Loss From Operations | $(5,905,329) | $(5,092,125) | $(16,016,955) | $(15,582,607) | | Net Loss | $(5,568,598) | $(5,096,530) | $(15,761,665) | $(15,563,005) | | Net Loss Per Share (Basic & Diluted) | $(0.21) | $(0.23) | $(0.61) | $(0.79) | - For the nine months ended September 30, 2021, the company recognized $4.0 million in revenue and $2.4 million in gross profit, compared to no revenue in the prior year period, primarily from the Arctic Vision License Agreement[16][150] - Net loss for the nine months ended September 30, 2021, was $(15.8) million, a slight increase from $(15.6) million in the prior year, despite revenue generation, due to increased operating expenses[16] - Research and development expenses increased by 14% to $11.3 million for the nine months ended September 30, 2021, driven by new hiring for commercialization and increased facilities costs, partially offset by higher cost reimbursements[16][153] - General and administrative expenses rose by 25% to $7.1 million for the nine months ended September 30, 2021, mainly due to increased salaries, sales and marketing efforts for MydCombi, and higher insurance and travel expenses[16][154] Condensed Statements of Changes in Stockholders' Equity This section outlines the changes in Eyenovia's stockholders' equity for the nine months ended September 30, 2021 Changes in Stockholders' Equity (Nine Months Ended September 30, 2021) | Item | Shares | Common Stock Amount | Additional Paid-In Capital | Accumulated Deficit | Total Stockholders' Equity |\ | :---------------------------- | :----------- | :------------------ | :------------------------- | :------------------ | :------------------------- |\ | Balance - January 1, 2021 | 24,978,585 | $2,498 | $92,742,306 | $(77,440,919) | $15,303,885 |\ | Exercise of stock warrants | 644,992 | $65 | $1,530,925 | — | $1,530,990 |\ | Stock-based compensation | — | — | $656,913 | — | $656,913 |\ | Net loss | — | — | — | $(5,351,667) | $(5,351,667) |\ | Balance - March 31, 2021 | 25,623,577 | $2,563 | $94,930,144 | $(82,792,586) | $12,140,121 |\ | Exercise of stock warrants | 232,022 | $23 | $572,978 | — | $573,001 |\ | Exercise of stock options | 91,047 | $9 | $130,081 | — | $130,090 |\ | Issuance of SVB warrants | — | — | $351,390 | — | $351,390 |\ | Stock-based compensation | — | — | $637,355 | — | $637,355 |\ | Net loss | — | — | — | $(4,841,400) | $(4,841,400) |\ | Balance - June 30, 2021 | 25,946,646 | $2,595 | $96,621,948 | $(87,633,986) | $8,990,557 |\ | Exercise of stock options | 16,539 | $2 | $46,710 | — | $46,712 |\ | Stock-based compensation | — | — | $777,467 | — | $777,467 |\ | Net loss | — | — | — | $(5,568,598) | $(5,568,598) |\ | Balance - September 30, 2021 | 25,963,185 | $2,597 | $97,446,125 | $(93,202,584) | $4,246,138 | - Total stockholders' equity significantly decreased from $15.3 million at January 1, 2021, to $4.2 million at September 30, 2021, primarily due to accumulated net losses totaling $(15.8) million during the period[18] - Additional paid-in capital increased by approximately $4.7 million, driven by the exercise of stock warrants and options, stock-based compensation, and the issuance of SVB warrants[18] Condensed Statements of Cash Flows This section details Eyenovia's cash flows from operating, investing, and financing activities for the nine months ended September 30, 2021 and 2020 Condensed Statements of Cash Flows Highlights (Nine Months Ended September 30) | Cash Flow Activity (USD) | 9 Months Ended Sep 30, 2021 | 9 Months Ended Sep 30, 2020 |\ | :----------------------------------- | :-------------------------- | :-------------------------- |\ | Net Cash Used In Operating Activities | $(14,997,807) | $(11,853,369) |\ | Net Cash Used In Investing Activities | $(1,165,066) | $(202,046) |\ | Net Cash Provided By Financing Activities | $9,166,916 | $20,767,392 |\ | Net (Decrease) Increase in Cash and Cash Equivalents | $(6,995,957) | $8,711,977 |\ | Cash and cash equivalents - End of Period | $21,375,871 | $22,864,578 | - Net cash used in operating activities increased to $(15.0) million for the nine months ended September 30, 2021, from $(11.9) million in the prior year, primarily due to higher net loss and changes in operating assets and liabilities[26][161] - Net cash provided by financing activities decreased significantly to $9.2 million in 2021 from $20.8 million in 2020, mainly due to lower proceeds from common stock sales and warrants, partially offset by a $7.5 million SVB loan[26][163] - The company experienced a net decrease in cash and cash equivalents of $(7.0) million for the nine months ended September 30, 2021, resulting in an ending balance of $21.4 million, including restricted cash[26][29] Notes to Unaudited Condensed Financial Statements This section provides detailed explanations of the company's business, significant accounting policies, and specific financial line items Note 1 – Business Organization, Nature of Operations and Basis of Presentation This note describes Eyenovia's business as a clinical-stage ophthalmic biopharmaceutical company and its basis of financial statement presentation - Eyenovia, Inc. is a clinical-stage ophthalmic biopharmaceutical company developing microdose array print (MAP™) therapeutics using its Optejet® delivery system[32] - The FDA reclassified MydCombi, a pupil dilation formulation, as a drug-device combination product, requiring an expedited resubmission of the new drug application[33] Note 2 – Summary of Significant Accounting Policies This note outlines Eyenovia's critical accounting policies, including revenue recognition, going concern, and EPS calculations - The company had $13.5 million in unrestricted cash and an accumulated deficit of $93.2 million as of September 30, 2021, raising substantial doubt about its ability to continue as a going concern without further capital or recurring revenue[36] - Restricted cash of $7,875,000 was established as collateral for the Silicon Valley Bank loan, which will become callable by SVB on November 30, 2021, due to the MydCombi FDA reclassification[41][74] Potentially Dilutive Shares Excluded from EPS Calculation | Security Type | September 30, 2021 | September 30, 2020 |\ | :------------ | :----------------- | :----------------- |\ | Options | 4,305,980 | 3,410,540 |\ | Warrants | 1,226,183 | 2,095,993 |\ | Total | 5,532,163 | 5,506,533 | - Revenue is primarily generated through research, development, and commercialization agreements, including upfront license fees, milestone payments, and royalties, recognized under ASC 606[46][50] Note 3 – Prepaid Expenses and Other Current Assets This note details the composition and changes in Eyenovia's prepaid expenses and other current assets Prepaid Expenses and Other Current Assets (September 30, 2021 vs. December 31, 2020) | Item | Sep 30, 2021 | Dec 31, 2020 |\ | :------------------------------------ | :----------- | :----------- |\ | Payroll tax receivable | $297,494 | $151,942 |\ | Prepaid insurance expenses | $413,648 | $110,094 |\ | Prepaid research and development expenses | $30,542 | — |\ | Prepaid general and administrative expenses | $105,941 | — |\ | Total prepaid expenses and other current assets | $1,123,289 | $453,478 | - Total prepaid expenses and other current assets increased by approximately $670,000, primarily driven by higher prepaid insurance expenses and new prepaid R&D and G&A expenses[61] Note 4 – Accrued Compensation This note provides a breakdown of Eyenovia's accrued compensation liabilities Accrued Compensation (September 30, 2021 vs. December 31, 2020) | Item | Sep 30, 2021 | Dec 31, 2020 |\ | :----------------------- | :----------- | :----------- |\ | Accrued bonus expenses | $895,253 | $938,873 |\ | Accrued payroll expenses | $288,983 | $211,799 |\ | Total accrued compensation | $1,184,236 | $1,150,672 | - Total accrued compensation slightly increased by $33,564, with a decrease in accrued bonus expenses offset by an increase in accrued payroll expenses[62] Note 5 – Accrued Expenses and Other Current Liabilities This note details the composition and changes in Eyenovia's accrued expenses and other current liabilities Accrued Expenses and Other Current Liabilities (September 30, 2021 vs. December 31, 2020) | Item | Sep 30, 2021 | Dec 31, 2020 |\ | :------------------------------------ | :----------- | :----------- |\ | Accrued research and development expenses | $181,241 | $348,254 |\ | Accrued consulting and professional services | $243,979 | $235,355 |\ | Accrued licensing fees | — | $804,447 |\ | Accrued interest | $31,250 | $3,068 |\ | Total accrued expenses and other current liabilities | $552,336 | $1,480,692 | - Total accrued expenses and other current liabilities decreased significantly by approximately $928,000, primarily due to the absence of accrued licensing fees in 2021 and lower accrued R&D expenses[65] Note 6 – Notes Payable This note describes Eyenovia's various notes payable, including the SVB loan and PPP loan forgiveness Notes Payable (September 30, 2021 vs. December 31, 2020) | Loan Type | Sep 30, 2021 Total | Dec 31, 2020 Total |\ | :---------------------------- | :----------------- | :----------------- |\ | BankDirect Capital Finance loan | $158,101 | — |\ | Paycheck Protection Program loan | — | $463,353 |\ | Silicon Valley Bank loan | $7,123,936 | — |\ | Total | $7,282,037 | $463,353 | - The company received full loan forgiveness for its $463,353 PPP Loan in August 2021, recorded as other income[69] - A $7.5 million loan from Silicon Valley Bank (SVB) was secured in May 2021, with $7.1 million outstanding as of September 30, 2021. The loan was fully classified as current due to the FDA's reclassification of MydCombi, making the restricted cash callable by SVB[70][74] Note 7 – Commitments and Contingencies This note outlines Eyenovia's contractual commitments and potential contingencies, including licensing agreements - Under the Arctic Vision License Agreement, the company recognized the full $4.0 million deferred license fee and $1.6 million deferred license costs in the nine months ended September 30, 2021, upon submission of trial data for MicroPine and MicroLine[84][150] - An amendment to the Arctic Vision License Agreement in September 2021 included a $250,000 upfront payment and potential $2.0 million milestone payments for the MicroStat product, with the upfront payment passed through to Senju[86][99] - The $10.0 million upfront payment from the Bausch License Agreement, signed in October 2020, remains a deferred license fee as of September 30, 2021, as the performance obligation related to administrative functions transfer has not yet been earned[89] Note 8 – Related Party Transactions This note discloses transactions between Eyenovia and related parties, such as lease agreements and license amendments - The company leases office and R&D space from a company owned by its VP of R&D, with rent expenses of $16,212 and $48,636 for the three and nine months ended September 30, 2021, respectively[94] - The Senju License Agreement was amended to exclude Greater China and South Korea from Senju's exclusive territory, in exchange for payments to Senju based on non-royalty license revenue and sales revenue, including a $250,000 upfront payment related to the Arctic Vision MicroStat amendment[99] Note 9 – Stockholders' Equity This note details changes in Eyenovia's stockholders' equity, including stock option and warrant activity and stock-based compensation Stock Option Activity (Nine Months Ended September 30, 2021) | Activity | Number of Options | Weighted Average Exercise Price |\ | :----------------------- | :---------------- | :------------------------------ |\ | Outstanding January 1, 2021 | 3,427,705 | $3.37 |\ | Granted | 1,003,536 | $5.56 |\ | Exercised | (121,261) | $2.07 |\ | Forfeited | (4,000) | $2.89 |\ | Outstanding September 30, 2021 | 4,305,980 | $3.89 |\ | Exercisable September 30, 2021 | 2,364,074 | $3.50 | Warrant Activity (Nine Months Ended September 30, 2021) | Activity | Number of Warrants | Weighted Average Exercise Price |\ | :----------------------- | :----------------- | :------------------------------ |\ | Outstanding January 1, 2021 | 2,011,313 | $2.43 |\ | Granted | 91,884 | $4.76 |\ | Exercised | (877,014) | $2.40 |\ | Outstanding September 30, 2021 | 1,226,183 | $2.69 |\ | Exercisable September 30, 2021 | 1,226,183 | $2.69 | - Stock-based compensation expense for the nine months ended September 30, 2021, was $2,071,735, with $5,787,351 of unrecognized expense remaining[115] - The company has an At-The-Market Offering agreement to sell up to $30 million in common stock, with no sales made through September 30, 2021[118][122] Note 10 – Employee Benefit Plans This note describes Eyenovia's employee benefit plans, specifically its 401(k) plan and matching contributions - The company's 401(k) plan includes a matching contribution of 100% of elective deferrals up to 4% of eligible earnings[123] - Matching contributions expense for the nine months ended September 30, 2021, was $144,917, an increase from $106,021 in the prior year[123] Note 11 – Subsequent Events This note reports significant events occurring after September 30, 2021, including equity sales and FDA reclassification - Subsequent to September 30, 2021, the company commenced sales under its At-The-Market Offering, generating approximately $12.8 million in gross proceeds and $12.4 million in net proceeds from the sale of 2,435,604 shares[124] - The FDA reclassified MydCombi as a drug-device combination product, requiring an expedited resubmission of the new drug application[125] - On October 27, 2021, the company granted 35,000 employee stock options with an exercise price of $4.06 per share[126] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations. This section provides management's perspective on Eyenovia's financial performance and condition for Q3 2021, detailing operations, expenses, and liquidity challenges Overview This section provides a high-level summary of Eyenovia's clinical-stage biopharmaceutical operations, product pipeline, and financial status - Eyenovia is a clinical-stage ophthalmic biopharmaceutical company developing microdose array print (MAP™) therapeutics using its Optejet® delivery system, aiming to improve safety and compliance for eye treatments[130] - The company's pipeline includes MicroPine for progressive myopia (Phase III CHAPERONE study), MicroLine for presbyopia (positive Phase III VISION-1 data, VISION-2 planned), and MydCombi for mydriasis (FDA reclassified as drug-device combination)[131][132][135][138] - Eyenovia has not yet received U.S. marketing approval for any product and has not generated product sales revenue[139] - The company's accumulated deficit was $93.2 million as of September 30, 2021, and it faces substantial doubt about its ability to continue as a going concern, requiring additional capital or recurring revenue[140][141] Financial Overview This section outlines Eyenovia's revenue recognition policies, expected trends in research and development, and general and administrative expenses - Revenue is generated from upfront licensing fees, milestone payments, and royalties from agreements like the Arctic Vision and Bausch License Agreements[142] - Research and development expenses are expensed as incurred and are expected to increase with ongoing initiatives, with some costs reimbursed by licensing partners[143][145] - General and administrative expenses are anticipated to rise due to increased headcount for commercialization and higher public company compliance costs[146] Results of Operations This section analyzes Eyenovia's financial performance for the three and nine months ended September 30, 2021, compared to prior periods Three Months Ended September 30, 2021 Compared with Three Months Ended September 30, 2020 This section compares Eyenovia's financial results for the three months ended September 30, 2021, against the same period in 2020 Research and Development Expenses (Three Months Ended September 30) | Expense Category | Sep 30, 2021 | Sep 30, 2020 |\ | :-------------------------------- | :----------- | :----------- |\ | Direct clinical and non-clinical | $818,015 | $1,745,880 |\ | Personnel-related | $1,386,602 | $890,771 |\ | Non-cash stock-based compensation | $489,121 | $346,294 |\ | Supplies and materials | $496,738 | $325,517 |\ | Facilities and other | $279,712 | $55,297 |\ | Total R&D expenses | $3,470,188 | $3,363,759 | - Total R&D expenses increased by 3% to $3.5 million, driven by higher personnel-related expenses, stock-based compensation, and facilities costs, partially offset by decreased direct clinical expenses due to cost reimbursements[148][151] - General and administrative expenses increased by 41% to $2.4 million, primarily due to a $0.3 million increase in salaries, a $0.3 million increase in sales and marketing for MydCombi, and higher insurance and travel expenses[149] Nine Months Ended September 30, 2021 Compared with Nine Months Ended September 30, 2020 This section compares Eyenovia's financial results for the nine months ended September 30, 2021, against the same period in 2020 - Revenue for the nine months ended September 30, 2021, was $4.0 million, with a corresponding cost of revenue of $1.6 million, recognized from the Arctic Vision License Agreement[150] Research and Development Expenses (Nine Months Ended September 30) | Expense Category | Sep 30, 2021 | Sep 30, 2020 |\ | :-------------------------------- | :----------- | :----------- |\ | Direct clinical and non-clinical | $4,696,396 | $5,076,662 |\ | Personnel-related | $3,886,683 | $2,533,439 |\ | Non-cash stock-based compensation | $1,138,331 | $1,002,150 |\ | Supplies and materials | $936,566 | $1,108,021 |\ | Facilities and other | $676,320 | $193,024 |\ | Total R&D expenses | $11,334,296 | $9,913,296 | - Total R&D expenses increased by 14% to $11.3 million, primarily due to increased personnel-related expenses, stock-based compensation, and facilities costs, partially offset by higher cost reimbursements and lower supplies costs[153] - General and administrative expenses increased by 25% to $7.1 million, mainly driven by higher salaries, sales and marketing for MydCombi, insurance, and travel expenses, partially offset by reduced professional services fees[154] Liquidity and Capital Resources This section discusses Eyenovia's cash position, working capital, and ability to fund operations, highlighting going concern issues - As of September 30, 2021, the company had $21.4 million in cash and cash equivalents (including $7.9 million restricted), working capital of $2.7 million, and an accumulated deficit of $93.2 million[156] - The company's ability to continue as a going concern is in substantial doubt, dependent on generating recurring revenue or raising additional capital[157] - Net cash used in operating activities was $(15.0) million for the nine months ended September 30, 2021, compared to $(11.9) million in the prior year[161] - Net cash provided by financing activities decreased to $9.2 million in 2021 from $20.8 million in 2020, primarily due to a $7.5 million SVB loan and proceeds from warrant/option exercises, offset by lower equity sales[163] - Subsequent to the reporting period, the company raised approximately $12.4 million in net proceeds from its at-the-market offering[164] Off-Balance Sheet Arrangements This section confirms Eyenovia has no material off-balance sheet arrangements impacting its financial condition - The company has no material off-balance sheet arrangements that would significantly affect its financial condition or results of operations[165] Critical Accounting Policies This section refers to Note 2 for details on Eyenovia's critical accounting policies - Critical accounting policies are detailed in Note 2 of the financial statements[166] Recently Adopted and Issued Accounting Pronouncements This section refers to Note 2 for information on recently adopted and issued accounting pronouncements - Information on recently adopted and issued accounting pronouncements is provided in Note 2 of the financial statements[167] Item 3. Quantitative and Qualitative Disclosures About Market Risk. As a smaller reporting company, Eyenovia, Inc. is not required to provide market risk disclosures for this period - Eyenovia is a smaller reporting company and is exempt from providing quantitative and qualitative disclosures about market risk[169] Item 4. Controls and Procedures. This section details the evaluation of Eyenovia's disclosure controls and procedures, confirming their effectiveness and reporting no material changes Evaluation of Disclosure Controls and Procedures This section confirms the effectiveness of Eyenovia's disclosure controls and procedures as of September 30, 2021 - As of September 30, 2021, management concluded that the company's disclosure controls and procedures were effective at a reasonable level to ensure timely and accurate reporting[173] Changes in Internal Control over Financial Reporting This section states that no material changes occurred in Eyenovia's internal control over financial reporting during Q3 2021 - No material changes in internal control over financial reporting occurred during the third quarter of 2021[174] PART II - OTHER INFORMATION This section covers legal proceedings, risk factors, equity sales, defaults, and exhibits for the reporting period Item 1. Legal Proceedings. This section indicates that there are no legal proceedings to report - No legal proceedings are reported[175] Item 1A. Risk Factors. As a smaller reporting company, Eyenovia, Inc. is exempt from providing risk factor disclosures for this period - Eyenovia is a smaller reporting company and is exempt from providing risk factor disclosures[176] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds. This section states that no unregistered sales of equity securities or issuer purchases occurred during the period - No recent sales of unregistered securities or purchases of equity securities by the issuer were reported[179] Item 3. Defaults Upon Senior Securities. This section indicates that there were no defaults upon senior securities during the reporting period - No defaults upon senior securities were reported[180] Item 4. Mine Safety Disclosures. This section states that mine safety disclosures are not applicable to the company - Mine safety disclosures are not applicable to the company[184] Item 5. Other Information. This section indicates that there is no other information to report - No other information is reported[186] Item 6. Exhibits. This section lists all exhibits filed with the Quarterly Report on Form 10-Q, including key agreements and certifications - Key exhibits include Amendment 1 to the License Agreement with Arctic Vision, Amendment 2 to the Exclusive License Agreement with Senju Pharmaceutical, and the First Amendment to Loan and Security Agreement with Silicon Valley Bank[188] SIGNATURES This section contains the official signatures certifying the accuracy of the quarterly report - The report was signed by John Gandolfo, Chief Financial Officer (Principal Financial and Accounting Officer), on November 12, 2021[193]