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Summary of Significant Accounting Policies | 3 Months Ended
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Mar. 31, 2024
Summary of Significant Accounting Policies |
Summary of Significant Accounting Policies | Note 2 – Summary of Significant Accounting Policies The Company disclosed its significant accounting policies in Note 2 – Summary of Significant Accounting Policies included in the 2023 Form 10-K. There have been no material changes to the Company’s significant accounting policies during the three months ended March 31, 2024, except as disclosed below. Liquidity and Going Concern As of March 31, 2024, the Company had unrestricted cash and cash equivalents of approximately $8.0 million and an accumulated deficit of approximately $156.4 million. For the three months ended March 31, 2024 and 2023, the Company incurred net losses of approximately $10.9 million and $5.7 million, respectively, and used cash in operations of approximately $9.9 million and $7.0 million, respectively. The Company does not have recurring revenue and has not yet achieved profitability. The Company expects to continue to incur cash outflows from operations for the near future. The Company expects that its research and development and general and administrative expenses will continue to increase and, as a result, it will eventually need to generate significant product revenues to achieve profitability. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date that these financial statements are issued. Implementation of the Company’s plans and its ability to continue as a going concern will depend on many factors, including the Company’s ability to successfully commercialize its products and services, competing technological and market developments, and the need to enter into collaborations with other companies, or acquire other companies or technologies to enhance or complement its product and service offerings. Additionally, the Company may need to raise further capital, through the sale of additional equity or debt securities. If the Company is unable to generate sufficient recurring revenues or secure additional capital, it may be required to curtail its research and development initiatives and take additional measures to reduce costs in order to conserve its cash. ​ Cash and Cash Equivalents The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents in the financial statements. As of March 31, 2024 and December 31, 2023, the Company had Treasury bills with original maturity dates of three months or less in the amounts of $2,039,357 and $5,450,118, respectively. The Company has cash deposits in financial institutions that, at times, may be in excess of Federal Deposit Insurance Corporation (“FDIC”) insurance limits. The Company has not experienced losses in such accounts and periodically evaluates the creditworthiness of its financial institutions. As of March 31, 2024 and December 31, 2023, the Company had cash and cash equivalent balances in excess of FDIC insurance limits of $7,301,681 and $14,243,870, respectively. Clinical Supply Arrangements Bausch + Lomb Ireland Limited (“Bausch + Lomb”) and Arctic Vision had contracted with the Company to manufacture and supply them with the appropriate drug-device combination products to conduct their clinical trials on a cost plus 10% mark-up basis. Pursuant to the Letter Agreement (as defined below) with Bausch + Lomb, as referenced in Note 8 – Commitments and Contingencies – Bausch License Agreements, the arrangement with Bausch + Lomb has been terminated, and all rights have been repurchased by Eyenovia. The arrangement with Arctic Vision is still in place. The Company’s licensing agreement with Arctic Vision represents a collaborative arrangement and Arctic Vision is not a customer with respect to the clinical supply arrangements. The Company’s policy is to (a) defer the materials and manufacturing costs in order to properly match them up against the income from the clinical supply arrangements; and (b) report the net income from the clinical supply arrangements as other income. Deferred clinical supply costs were $0.8 million and $4.3 million at March 31, 2024 and December 31, 2023, respectively. See Note 8 – Commitments and Contingencies –Defective Clinical Supply for additional information. Inventories Inventories are stated at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method. The cost of inventory that is sold to third parties is included within cost of sales. The Company will periodically review for slow-moving, excess or obsolete inventories. Inventory is primarily comprised of drug-device combination products, which are available for commercial sale, as follows: ​
​ | ​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | March 31, |  | December 31, | ​
​ |  | 2024 | ​ | 2023 | ​
Finished goods | ​ | $ | 452,218 | ​ | $ | 30,683 | ​
Raw materials | ​ |  | 3,061,642 | ​ |  | 79,115 | ​
Total inventory | ​ | $ | 3,513,860 | ​ | $ | 109,798 | ​
​ The Company has evaluated the net realizable value of the commercial inventory. The write-down of commercial inventory to net realizable value was $198,034 and $0 for the three months ended March 31, 2024 and 2023, respectively. Net Loss Per Share of Common Stock Basic net loss per share of common stock is computed by dividing net loss by the weighted average number of shares of common stock outstanding during the period, plus fully vested shares that are subject to issuance for little or no monetary consideration. Diluted loss per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock. The following table presents the computation of basic and diluted net loss per common share: ​
​ | ​ | ​ | ​ | ​ | ​ | ​
​ |  | For the Three Months Ended
​ | ​ | March 31,
​ |  | 2024 |  | 2023
Numerator: | ​ | ​ | ​ | ​ | ​ | ​
Net income (loss) | ​ | $ | (10,922,101) | ​ | $ | (5,739,366)
Net loss attributable to common stockholders | ​ | $ | (10,922,101) | ​ | $ | (5,739,366)
​ | ​ | ​ | ​ | ​ | ​ | ​
Denominator (weighted average quantities): | ​ |  | ​ | ​ |  | ​
Common shares issued | ​ |  | 46,471,045 | ​ |  | 37,380,976
Add: Undelivered vested restricted stock units | ​ |  | 135,745 | ​ |  | 29,611
Denominator for basic and diluted net loss per share | ​ |  | 46,606,790 | ​ |  | 37,410,587
​ | ​ | ​ | ​ | ​ | ​ | ​
Basic and diluted net loss per common share | ​ | $ | (0.23) | ​ | $ | (0.15)
​ The following securities are excluded from the calculation of weighted average diluted shares of common stock because their inclusion would have been anti-dilutive: ​
​ | ​ | ​ | ​ | ​
​ | ​ | March 31,
​ |  | 2024 |  | 2023
Warrants |  | 10,926,554 |  | 6,087,845
Options |  | 6,022,877 |  | 5,460,099
Convertible notes | ​ | 2,327,747 | ​ | 2,327,747
Restricted stock units |  | 106,019 |  | 150,578
Total potentially dilutive shares |  | 19,383,197 |  | 14,026,269
​ Subsequent Events The Company has evaluated subsequent events through the date which the financial statements were issued. Based upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would have required adjustment or disclosure in the financial statements, except as disclosed. Recently Issued Accounting Standards In November 2023, the FASB issued ASU 2023-07, Improvements to Reportable Segments Disclosures (Topic 280), which updates reportable segment disclosure requirements, primarily through enhanced disclosures about significant segment expenses on both an annual and interim basis. The guidance becomes effective for fiscal years beginning after December 15, 2023 and interim periods within fiscal years beginning after December 15, 2024, with early adoption permitted. Since this new ASU addresses only disclosures, the Company does not expect the adoption of this ASU to have any material effects on its financial condition, results of operations or cash flows. The Company is currently evaluating any new disclosures that may be required upon adoption of ASU 2023-07. In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures. The amendments in this update address investor requests for more transparency about income tax information through improvements to income tax disclosures primarily related to the rate reconciliation and income taxes paid information. This update also includes certain other amendments to improve the effectiveness of income tax disclosures. The amendments in ASU 2023-09 are effective for fiscal years beginning after December 15, 2024, with early adoption permitted. The Company is currently evaluating the impact of this standard, but does not expect it to have a material impact on its financial statements.

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