Eyenovia, Inc. (EYEN) 10K Annual Reports & 10Q SEC Filings

Announced positive results from Microline Phase 3 program as a potential treatment for presbyopia and received feedback from the FDA outlining a clear path forward for the program

Entered into co-development agreement with Formosa Pharmaceuticals

Company to host conference call and webcast today, March 30^th, at 4:30 pm ET

NEW YORK—March 30, 2023—Eyenovia, Inc. (Nasdaq: EYEN), a pre-commercial ophthalmic technology company developing the Optejet® delivery system for use both in combination with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive myopia as well as out-licensing for additional indications, today announced its financial and operating results for the fourth quarter and full-year ended December 31, 2022.

Fourth Quarter 2022 and Recent Business Developments

Announced U.S. Food and Drug Administration (FDA) acceptance of the Mydcombi NDA and Prescription Drug User Fee Act (PDUFA) action target date of May 8^th, 2023.

Announced positive results from Microline Phase 3 program as a potential treatment for presbyopia and received encouraging feedback from FDA outlining a clear path forward for the program.

Entered into a development collaboration agreement with Formosa Pharmaceuticals to combine Eyenovia’s Optejet® dispensing technology with Formosa’s APNT nanoparticle formulation platform for the potential development of new topical therapeutics in high-value ophthalmic indications with significant unmet medical needs.

Manufacturing facility in Redwood City is operational and producing clinical supply; legacy Reno facility is currently being inspected by the FDA as part of the Mydcombi review process; second facility in Reno anticipated to come online during the third quarter 2023.

Development partner Arctic Vision continues to enroll patients in its Phase 3 study of Microline (ARVN003) as a potential treatment for presbyopia in China.

Ended the fourth quarter of 2022 with approximately $22.9 million in total cash and cash equivalents.

Michael Rowe, Chief Executive Officer, commented, “We continue to make significant progress with our two lead programs, Mydcombi and Microline. Specifically, we are preparing for our May 8^th PDUFA date for Mydcombi which, if approved, would validate the Optejet dispensing technology that is core to all of our proprietary and partnered programs, and would transition us to a commercial stage company. We are in the middle of a FDA inspection of our manufacturing facility as part of that review process.”

The following information was filed by Eyenovia, Inc. (EYEN) on Thursday, March 30, 2023 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-K Annual Report statement of earnings and operation as management may choose to highlight particular information in the press release.

Please wait while we load the requested 10-K report or click the link below:

https://last10k.com/sec-filings/report/1682639/000141057823000511/eyen-20221231x10k.htm

View differences made from one year to another to evaluate Eyenovia, Inc.'s financial trajectory

Compare SEC Filings Year-over-Year (YoY) and Quarter-over-Quarter (QoQ) — *Sample 10-K Year-over-Year (YoY) Comparison*

Compare this 10-K Annual Report to its predecessor by reading our highlights to see what text and tables were ~~removed~~ , added and changed by Eyenovia, Inc..

Continue

Assess how Eyenovia, Inc.'s management team is paid from their Annual Proxy

Eyenovia, Inc.'s Definitive Proxy Statement (Form DEF 14A) filed after their 2023 10-K Annual Report includes:

Voting Procedures
Board Members
Executive Team
Salaries, Bonuses, Perks
Peers / Competitors

Continue

Rating
Learn More

Filter Sentiment:

All

Positive

Negative

Filter Category:

All

Revenue

Financial

Legal

Other

Filter Subcategory:

All

Product

Expense

Geography

Income

Other

Inside Eyenovia, Inc.'s 10-K Annual Report:

Revenue - Product Highlight
Net cash provided by financing activities for the year ended December 31, 2021 totaled approximately $21.5 million, which was primarily attributable to $12.4 million of net proceeds from the sale of common stock and warrants in our at-the-market offering pursuant to the Sales Agreement, dated May 14, 2021, with SVB Securities, $2.1 million of proceeds from exercises of stock warrants, $7.4 million of net proceeds from the credit facility with SVB Securities, $0.2 million of proceeds from the exercise of stock options, offset by $0.7 million from the repayments of notes payable.

Financial - Shares Highlight
Up to $5,000,000 of the principal amount outstanding may be converted at the option of the lender into shares of the Company's common stock at a conversion price of $2.148 per share, subject to typical anti-dilution adjustments.
Revenue - Product Highlight
Net cash provided by financing activities for the year ended December 31, 2022 totaled approximately $21.5 million, which was primarily attributable to $14.9 million of net proceeds from the sale of common stock and warrants from a registered direct offering, $5.3 million of net proceeds from the sale of common stock and warrants in our at-the-market offering pursuant to the Sales Agreement with SVB Securities LLC, or SVB Securities (formerly known as SVB Leerink LLC), and $9.5 million of net proceeds from the credit facility with Avenue, offset by $8.2 million from the repayment of notes payable.
Financial - Expense Highlight
The decrease in direct clinical and non-clinical expenses resulted from the sharp decrease in expenses resulting from Bausch + Lomb assuming full control of its clinical trial in December 2021 and the Vision 2 study in 2022 costing less than the Vision 1 study completed in 2021.
Revenue - Product Highlight
Lower volume of medication exposes the ocular surface to less active ingredient and preservatives, potentially reducing ocular stress and surface damage and improving tolerability.
Legal - Other
The increase in professional fees...Read more
Financial - Expense
General and administrative expenses consisted...Read more
Financial - Expense
If we are unable to...Read more
Revenue - Product
If we are unable to...Read more
Other - Other
Avenue Loan Agreement On November...Read more
Revenue - Product
Accordingly, the upfront payment was...Read more
Financial - Expense
Research and development expenses consisted...Read more
Financial - Expense
General and Administrative Expenses General...Read more
Revenue - Product
To determine revenue recognition for...Read more
Financial - Expense
During the next twelve months...Read more
Revenue - Product
The decrease in sales and...Read more
Financial - Expense
Research and Development Expenses Research...Read more
Revenue - Geography
The following represent our most...Read more
Revenue - Geography
After twelve months we have...Read more
Financial - Income
Net other income for the...Read more
Revenue - Product
We must make significant judgments...Read more
Other - Other
Milestone payments represent variable consideration...Read more
Other - Other
These statements are often identified...Read more
Other - Other
Certain of our estimates could...Read more
Financial - Income
Other Income (Expense) Other income...Read more
Other - Other
We will pay between 30...Read more
Financial - Expense
The increase in other expense...Read more
Financial - Expense
We record costs for some...Read more

Financial Statements, Disclosures and Schedules

Inside this 10-K Annual Report

Material Contracts, Statements, Certifications & more

Eyenovia, Inc. provided additional information to their SEC Filing as exhibits

Exhibit 4.1: Instruments Defining The Rights Of Security Holders, Including Indentures

Exhibit 10.30: Material Contract

Exhibit 10.31: Material Contract

Exhibit 10.32: Material Contract

Exhibit 10.33: Material Contract

Exhibit 23.1: Consents Of Experts And Counsel

Exhibit 31.1: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 31.2: Rule 13A-14(A)/15D-14(A) Certification

Exhibit 32.1: Section 1350 Certification

Exhibit 32.2: Section 1350 Certification

Ticker: EYEN
CIK: 1682639
Form Type: 10-K Annual Report
Accession Number: 0001410578-23-000511
Submitted to the SEC: Fri Mar 31 2023 9:43:43 AM EST
Accepted by the SEC: Fri Mar 31 2023
Period: Saturday, December 31, 2022
Industry: Pharmaceutical Preparations