EYENOVIA, INC. Files 2023 Annual Report on Form 10-K

TL;DR

<b>EYENOVIA, INC. has submitted its 2023 Form 10-K detailing financial performance and corporate actions.</b>

AI Summary

EYENOVIA, INC. (HYPD) filed a Annual Report (10-K) with the SEC on March 18, 2024. EYENOVIA, INC. filed its annual report on Form 10-K for the fiscal year ended December 31, 2023. The filing includes financial data for the fiscal years ending December 31, 2023, 2022, and 2021. Key financial statement elements such as Retained Earnings, Additional Paid-In Capital, and Common Stock are detailed for these periods. Information regarding stock options and warrants, including exercise prices and purchase agreements, is presented. The company's business address is located at 295 Madison Avenue, Suite 2400, New York, NY 10017.

Why It Matters

For investors and stakeholders tracking EYENOVIA, INC., this filing contains several important signals. This 10-K filing provides a comprehensive overview of EYENOVIA's financial health and operational status for the fiscal year 2023, crucial for investors assessing the company's performance and future prospects. The detailed financial statements and disclosures within the report are essential for understanding the company's capital structure, equity instruments, and any significant financial events or agreements from the past fiscal year.

Risk Assessment

Risk Level: medium — EYENOVIA, INC. shows moderate risk based on this filing. The filing is a standard 10-K, which typically contains a broad range of information. Specific risks are not detailed in the provided header, but the nature of a 10-K suggests potential market, operational, and financial risks inherent to a publicly traded company in the pharmaceutical sector.

Analyst Insight

Review the detailed financial statements and risk factors within the full 10-K filing to assess EYENOVIA's financial position and identify potential investment risks and opportunities.

Key Numbers

• 2023-12-31 — Fiscal Year End (Reporting period)
• 2024-03-18 — Filing Date (Date of submission)
• 104 — Public Document Count (Number of documents in the filing)

Key Players & Entities

• EYENOVIA, INC. (company) — Filer name
• 2023-12-31 (date) — Fiscal year end
• 2024-03-18 (date) — Filing date
• 295 Madison Avenue, Suite 2400, New York, NY 10017 (address) — Business address
• PHARMACEUTICAL PREPARATIONS [2834] (industry) — Standard Industrial Classification
• 0001682639 (company_id) — Central Index Key

FAQ

Industry Context

EYENOVIA, INC. operates within the Pharmaceutical Preparations industry (SIC code 2834). This sector involves the research, development, manufacturing, and marketing of drugs and medicines.

Regulatory Implications

As a publicly traded company, EYENOVIA, INC. is subject to the regulations of the U.S. Securities and Exchange Commission (SEC), requiring regular filings such as this 10-K annual report.

What Investors Should Do

1. Thoroughly review the full 10-K document for detailed financial statements, including balance sheets, income statements, and cash flow statements.
2. Analyze the Management's Discussion and Analysis (MD&A) section for insights into the company's performance, strategies, and outlook.
3. Examine the Risk Factors section for potential challenges and uncertainties facing EYENOVIA, INC.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-03-18: Filing Date — Date the 10-K was officially submitted to the SEC.

Year-Over-Year Comparison

This is the initial filing data extracted from the header of the 2023 10-K. Comparative data from the previous year's filing (2022 10-K) is not available in this extract.

Key Financial Figures

• $0.0001 — ange on which registered Common Stock, $0.0001 Par Value EYEN The Nasdaq Stock Mar
• $2.37 — 30, 2023 (based on the closing price of $2.37 on June 30, 2023, the last trading day
• $10.0 million — ment, we received an upfront payment of $10.0 million and we were eligible to receive up to a
• $35.0 million — re eligible to receive up to a total of $35.0 million in additional payments, based on the ac
• $2 million — In this agreement, we agreed to pay B+L $2 million in cash and an additional $3 million in
• $3 million — +L $2 million in cash and an additional $3 million in common stock upon successful transfe
• $4.25 million — nded, we received an upfront payment of $4.25 million before any payments to Senju Pharmaceut
• $37.7 million — dition, we may receive up to a total of $37.7 million in additional payments, based on variou
• $2,000,000 — front payment in an aggregate amount of $2,000,000 which consisted of (a) cash in the amou
• $1,000,000 — consisted of (a) cash in the amount of $1,000,000 and (b) 487,805 shares of common stock
• $122,945 — lued at $1,000,000. We also capitalized $122,945 of transaction costs in connection with
• $4 million — In addition, we must pay Formosa up to $4 million upon the achievement of certain develop
• $80 million — ertain development milestones and up to $80 million upon the achievement of certain sales m

Filing Documents

• eyen-20231231x10k.htm (10-K) — 2980KB
• eyen-20231231xex10d38.htm (EX-10.38) — 66KB
• eyen-20231231xex23d1.htm (EX-23.1) — 5KB
• eyen-20231231xex31d1.htm (EX-31.1) — 12KB
• eyen-20231231xex31d2.htm (EX-31.2) — 12KB
• eyen-20231231xex32d1.htm (EX-32.1) — 6KB
• eyen-20231231xex32d2.htm (EX-32.2) — 7KB
• eyen-20231231xex97d1.htm (EX-97.1) — 21KB
• eyen-20231231x10k002.jpg (GRAPHIC) — 3KB
• eyen-20231231x10k003.jpg (GRAPHIC) — 3KB
• eyen-20231231x10k004.jpg (GRAPHIC) — 5KB
• eyen-20231231x10k005.jpg (GRAPHIC) — 53KB
• eyen-20231231x10k006.jpg (GRAPHIC) — 12KB
• eyen-20231231x10k007.jpg (GRAPHIC) — 17KB
• eyen-20231231x10k008.jpg (GRAPHIC) — 18KB
• eyen-20231231x10k009.jpg (GRAPHIC) — 36KB
• eyen-20231231x10k010.jpg (GRAPHIC) — 14KB
• eyen-20231231x10k011.jpg (GRAPHIC) — 30KB
• eyen-20231231x10k012.jpg (GRAPHIC) — 12KB
• eyen-20231231x10k013.jpg (GRAPHIC) — 13KB
• eyen-20231231x10k014.jpg (GRAPHIC) — 27KB
• eyen-20231231x10k015.jpg (GRAPHIC) — 12KB
• eyen-20231231x10k016.jpg (GRAPHIC) — 13KB
• eyen-20231231x10k017.jpg (GRAPHIC) — 4KB
• eyen-20231231x10k018.jpg (GRAPHIC) — 14KB
• eyen-20231231x10k019.jpg (GRAPHIC) — 35KB
• 0001410578-24-000226.txt (&nbsp;) — 12327KB
• eyen-20231231.xsd (EX-101.SCH) — 89KB
• eyen-20231231_cal.xml (EX-101.CAL) — 65KB
• eyen-20231231_def.xml (EX-101.DEF) — 250KB
• eyen-20231231_lab.xml (EX-101.LAB) — 603KB
• eyen-20231231_pre.xml (EX-101.PRE) — 496KB
• eyen-20231231x10k_htm.xml (XML) — 2029KB

Business

Item 1. Business 5

Risk Factors

Item 1A. Risk Factors 43

Unresolved Staff Comments

Item 1B. Unresolved Staff Comments 84

Cybersecurity

Item 1C. Cybersecurity 84

Properties

Item 2. Properties 85

Legal Proceedings

Item 3. Legal Proceedings 85

Mine Safety Disclosures

Item 4. Mine Safety Disclosures 85 PART II

Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 86

[Reserved]

Item 6. [Reserved] 86

Management's Discussion and Analysis of Financial Condition and Results of Operations

Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations 87

Quantitative and Qualitative Disclosures About Risk

Item 7A. Quantitative and Qualitative Disclosures About Risk 95

Financial Statements and Supplementary Data

Item 8. Financial Statements and Supplementary Data 95

Changes in and Disagreements With Accountants on Accounting and Financial Disclosures

Item 9. Changes in and Disagreements With Accountants on Accounting and Financial Disclosures 95

Controls and Procedures

Item 9A. Controls and Procedures 95

Other Information

Item 9B. Other Information 96

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections 96 PART III

Directors, Executive Officers and Corporate Governance

Item 10. Directors, Executive Officers and Corporate Governance 97

Executive Compensation

Item 11. Executive Compensation 97

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 98

Certain Relationships and Related Transactions, and Director Independence

Item 13. Certain Relationships and Related Transactions, and Director Independence 98

Principal Accountant Fees and Services

Item 14. Principal Accountant Fees and Services 98 PART IV

Exhibits, Financial Statement Schedules

Item 15. Exhibits, Financial Statement Schedules 99

Form 10-K Summary

Item 16. Form 10-K Summary 103

Signatures

Signatures 104 Table of Contents PART I CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS This Annual Report on Form 10-K contains "forward-looking statements" that involve risks and uncertainties, as well as assumptions that, if they never materialize or prove incorrect, could cause our results to differ materially from those expressed or implied by such forward-looking statements. The statements contained in this Annual Report on Form 10-K that are not purely historical are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or Exchange Act. Such forward-looking statements include our estimates regarding expenses, future revenue, capital requirements and our need for additional financing and other financial items; any statements of the plans, strategies and objectives of management for future operations; any statements about the advantages of our product candidates and platform technology; estimates regarding the potential market opportunity for our product candidates and platform technology; statements regarding our clinical trials; factors that may affect our operating results; statements about our ability to establish and maintain intellectual property rights; statements about our ability to retain key personnel and hire necessary employees and appropriately staff our operations; statements related to future capital expenditures; statements related to future economic conditions or performance; and other matters that do not relate strictly to historical facts or statements of assumptions underlying any of the foregoing. Forward-looking statements are often identified by the use of words such as, but not limited to, "anticipate," "believe," "can," "continue," "could," "estimate," "expect," "intend," "may," "might," "will," "plan," "project," "seek," "should," "target," "would," and similar expressions or variation

Business

Item 1. Business. Corporate Information We were organized as a corporation under the laws of the State of Florida on March 12, 2014 under the name "PGP Holdings V, Inc." On May 5, 2014, we changed our name to Eyenovia, Inc. On October 6, 2014, we reincorporated in the State of Delaware by merging into Eyenovia, Inc., a Delaware corporation. Our principal executive office is located at 295 Madison Avenue, Suite 2400, New York, NY 10017, and our phone number is (833) 393-6684. Our website is www.eyenovia.com . Information contained on, or that can be accessed through, our website is not incorporated by reference into this report, and you should not consider information on our website to be part of this report. Overview We are an ophthalmic technology company commercializing Mydcombi (tropicamide and phenylephrine HCL ophthalmic spray) for inducing mydriasis for routine diagnostic procedures and in conditions where short term pupil dilation is desired, preparing for the commercialization of clobetasol propionate ophthalmic suspension 0.05% ("clobetasol propionate"), for the treatment of post-operative inflammation and pain following ocular surgery, and developing the Optejet delivery system both for use in combination with our own drug-device therapeutic programs and for out-licensing for use in combination with therapeutics for additional indications. Our aim is to improve the delivery of topical ophthalmic medication through the ergonomic design of the Optejet which facilitates ease-of-use and delivery of a more physiologically appropriate medication volume, with the goal to reduce side effects and improve tolerability, and introduce digital health technology to improve therapy compliance and ultimately medical outcomes. The ergonomic and functional design of the Optejet allows for horizontal drug delivery and eliminates the need to tilt the head back or the manual dexterity to squeeze a bottle to administer medications. Drug is delivered in a microscopic arr

View Full Filing

View this 10-K filing on SEC EDGAR