Eyenovia Amends 8-K/A: Updates Apersure Market Size, NDA Costs

Ticker: HYPD · Form: 8-K/A · Filed: Jan 31, 2024 · CIK: 1682639

Eyenovia, INC. 8-K/A Filing Summary
FieldDetail
CompanyEyenovia, INC. (HYPD)
Form Type8-K/A
Filed DateJan 31, 2024
Risk Levellow
Pages4
Reading Time5 min
Key Dollar Amounts$0.0001, $250 million, $1.8 billion, $2.7 billion, $236 million
Sentimentneutral

Complexity: simple

Sentiment: neutral

Topics: amendment, investor-presentation, regulatory-filing, product-update

TL;DR

**Eyenovia just updated its Apersure market size and NDA cost estimates in an amended filing, giving investors clearer financial picture.**

AI Summary

Eyenovia, Inc. filed an amended 8-K/A on January 31, 2024, to update its investor presentation from January 25, 2024. The amendment specifically revises market size opportunity references and clarifies the cost of an NDA filing for its product, Apersure, on slides 16, 17, and 28. This matters to investors because it provides more accurate financial and market data, which could influence their valuation of the company's future prospects, especially regarding Apersure's potential market and regulatory costs.

Why It Matters

This filing provides updated, more accurate financial and market information for Eyenovia's Apersure product, which is crucial for investors making informed decisions about the company's valuation and future growth potential.

Risk Assessment

Risk Level: low — This filing is an amendment to clarify previously provided information, not to announce a new, significant event, thus posing low risk.

Analyst Insight

A smart investor would review the updated investor presentation (Exhibit 99.1) to understand the revised market size opportunities and NDA cost estimates for Apersure, then re-evaluate their valuation models for Eyenovia based on this more accurate data.

Key Players & Entities

FAQ

What was the primary purpose of Eyenovia, Inc.'s 8-K/A filing on January 31, 2024?

The primary purpose of the 8-K/A filing was to amend the Current Report on Form 8-K filed on January 25, 2024, by providing an updated version of the investor presentation (Exhibit 99.1).

What specific information was updated in the investor presentation furnished with the 8-K/A?

The updated investor presentation revised market size opportunity references and clarified the cost of an NDA filing for Apersure, as detailed on slides 16, 17, and 28.

Did the 8-K/A filing introduce any other changes to the original 8-K or its exhibits?

No, the filing explicitly states that "No other changes have been made to the Original 8-K or to Exhibit 99.1 furnished hereto," besides the updated investor presentation.

What is the product mentioned in the filing for which NDA filing costs were clarified?

The product mentioned is Apersure, for which the cost of an NDA (New Drug Application) filing was clarified.

What is the Central Index Key (CIK) for Eyenovia, Inc.?

The Central Index Key (CIK) for Eyenovia, Inc. is 0001682639.

Filing Stats: 1,247 words · 5 min read · ~4 pages · Grade level 12 · Accepted 2024-01-31 08:13:19

Key Financial Figures

Filing Documents

01. Regulation FD Disclosure

Item 7.01. Regulation FD Disclosure. On January 25, 2024, Eyenovia released an updated investor presentation, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference. Eyenovia is developing topical ophthalmic medications that utilize its novel, patented Optejet drug-device dispensing platform to address large market indications with significant unmet medical needs. Numerous studies have demonstrated the ability of the Optejet to achieve efficacy with up to 80% less medication than traditional eye drops, resulting in increased local tolerability and decreased systemic exposure to both drug and preservatives. The Optejet technology is protected by a comprehensive IP portfolio, with many claims in effect beyond 2031. Complementing its Optejet device, Eyenovia is developing its Optecare suite of digital applications which leverages the onboard programming and Bluetooth technology in the Optejet to track usage and boost compliance through reminders sent to the patient, which may result in improved patient outcomes. This also represents a potential additional revenue stream for eye doctors under a CPT code for "Remote Therapeutic Monitoring Treatment Management Services." Eyenovia currently has one commercial asset, Mydcombi for mydriasis (in-office and surgical pupil dilation), which is currently being launched commercially. Eyenovia estimates this to be a $250 million market annually, and the updated investor presentation contains several testimonials from early adopters of the technology. Mydcombi represents the first FDA approved drug in the Optejet, providing important validation of the technology. Eyenovia in-licensed its second asset, APP13007 for pain and inflammation following ocular surgery, from Formosa Pharmaceuticals in August of 2023. APP13007 has an FDA PDUFA date of March 4, 2024. APP13007 utilizes Formosa's APNT platform which reduces an active pharmaceutical ingredient's particle size

01. Financial Statements and Exhibits

Item 9.01. Financial Statements and Exhibits. (d)Exhibits Exhibit No. Description 99.1 Eyenovia, Inc. Updated Corporate Presentation, dated January 2024 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. EYENOVIA, INC. Date: January 31, 2024 /s/ John Gandolfo John Gandolfo Chief Financial Officer

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