Eyenovia Reports Third Quarter 2023 Financial Results and Provides Business Update
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Eyenovia Reports Third Quarter 2023 Financial Results and Provides Business Update
Announced FDA approval of
Company to host conference call and webcast today,
Third Quarter 2023 and Recent Business Developments
- Acquired the
U.S.commercial rights to APP13007 for post-surgical ocular pain and inflammation from Formosa Pharmaceuticals. If approved, APP13007 would complement Eyenovia’s commercially approved mydriasis product, Mydcombi, and allow for the generation of additional near-term revenue. A New Drug Application (NDA) for APP13007 is currently under review by the FDA, which has assigned a PDUFA action date of March 4, 2024.
- Announced the appointment of senior finance executive Mr.
Michael Geltzeilerto Eyenovia’s Board as an independent director and Chair of the Audit Committee.
- Announced FDA approval of
Coastline Internationalas contract manufacturer for Mydcombi cartridge subassemblies, enabling a national launch in early 2024.
- Initiated training of ophthalmic technicians in the use of Mydcombi through sponsorship of a course at the
International Joint Commission on Allied Health Personnelin Ophthalmology (IJCAHPO) 51st Annual Continuing Education (ACE) program.
- Advanced its Gen-2 Optejet device and anticipates shipping to MicroPine partners Bausch and Lomb and Arctic Vision by year-end 2023.
- Continued to validate its manufacturing facilities in
Redwood City, CAand Reno, NV, the former having a PDUFA date in February 2024for use as a commercial facility.
- Presented data from a study of the preservative-free microbial integrity of the Optejet® at the
American Academyof Optometry’s “Academy 2023 New Orleans” Annual Meeting in October. The study successfully demonstrated the Optejet’s ability to maintain product sterility even when exposed to a microbial load that exceeds typical environmental conditions.
“We were also pleased to announce recently that
"We have made the strategic decision to prioritize our current Gen-2 Optejet manufacturing capabilities to ensure that our partners, Bausch and Lomb and Arctic Vision, have this advanced product for their pediatric myopia studies by the end of this year. This will shift the manufacture of registration batches of our pre-NDA presbyopia candidate, Apersure, to the first quarter of 2024. We see no downside to this change as the nascent presbyopia market continues to evolve and mature, as evidenced by the disappointing performance of the only available eye drop product for this indication. As new entrants come into the presbyopia market and revitalize it, we look forward to introducing Apersure in the highly differentiated and desirable Optejet dispenser.
“We are also excited to announce today the appointment of Mr.
“With three distinct sources of potential growth – internally developed programs, complementary product acquisitions that can be further developed in the Optejet, and strategic partnerships that license the Optejet for additional indications – I believe we have firmly established ourselves as a leader in topical ophthalmic medication delivery, and I am excited about the many opportunities that are in front of us,”
Third Quarter 2023 Financial Review
For the third quarter of 2023, net loss was approximately
Research and development expenses totaled approximately
For the third quarter of 2023, general and administrative expenses were approximately
Total operating expenses for the third quarter of 2023 were approximately
Conference Call and Webcast
The conference call is scheduled to begin at
To access the Call me™ feature, which avoids having to wait for an operator, click here.
A live webcast of the conference call will also be available on the investor relations page of the Company's corporate website at www.eyenovia.com. After the live webcast, the event will be archived on Eyenovia’s website for one year.
IMPORTANT SAFETY INFORMATION for MYDCOMBI™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%
MYDCOMBI is indicated to induce mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired
CONTRAINDICATIONS: In patients with known hypersensitivity to any component of the formulation
WARNINGS AND PRECAUTIONS
FOR TOPICAL OPHTHALMIC USE. NOT FOR INJECTION
This preparation may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reaction and behavioral disturbance due to hypersensitivity to anticholinergic drugs should be considered.
Mydriatics may produce a transient elevation of intraocular pressure.
Significant elevations in blood pressure have been reported. Caution in patients with elevated blood pressure.
Rebound miosis has been reported one day after installation.
Remove contact lenses before using.
Atropine-like Drugs: May exaggerate the adrenergic pressor response
Cholinergic Agonists and Ophthalmic Cholinesterase Inhibitors: May interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors
Potent Inhalation Anesthetic Agents: May potentiate cardiovascular depressant effects of some inhalation anesthetic agents
- Most common ocular adverse reactions include transient blurred vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort. Increased intraocular pressure has been reported following the use of mydriatics.
- Systemic adverse reactions including dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.
To report SUSPECTED ADVERSE REACTIONS, contact
Please go to www.mydcombi.com for FULL PRESCRIBING INFORMATION
About Eyenovia, Inc.
In addition to commercializing Mydcombi, in
For more information, visit www.eyenovia.com.
The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.
Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. Forward-looking statements include, but are not limited to, statements that express our intentions, beliefs, expectations, strategies, predictions or any other statements relating to our future activities or other future events or conditions, including estimated market opportunities for our products, product candidates and platform technology. These statements are based on current expectations, estimates and projections about our business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Therefore, actual outcomes and results may, and in some cases are likely to, differ materially from what is expressed or forecasted in the forward-looking statements. In addition, such statements could be affected by risks and uncertainties related to, among other things: risks of our clinical trials, including, but not limited to, the costs, design, initiation and enrollment, timing, progress and results of such trials; the timing of, and our ability to submit applications for, obtaining and maintaining regulatory approvals for our product candidates; the potential impacts of any disruptions on our supply chain, including the availability of sufficient components and materials used in our products and product candidates; the potential advantages of our products, product candidates and platform technology; the rate and degree of market acceptance and clinical utility of our products and product candidates; our estimates regarding the potential market opportunity for our products and product candidates; reliance on third parties to develop and commercialize our products and product candidates; the ability of us and our partners to timely develop, implement and maintain manufacturing, commercialization and marketing capabilities and strategies for our products and product candidates; the risk of defects in, or returns of, our products; intellectual property risks; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; our competitive position; and other risks described from time to time in the “Risk Factors” section of our filings with the
Chief Financial Officer
Eyenovia Investor Contact:
Eyenovia Media Contact:
Vice President, Commercial Operations
|Condensed Balance Sheets|
|Cash and cash equivalents||$||20,702,212||$||22,863,520|
|Deferred clinical supply costs||3,622,687||2,284,931|
|License fee and expense reimbursements receivable||397,014||1,183,786|
|Security deposits, current||-||119,550|
|Prepaid expenses and other current assets||1,760,824||1,190,719|
|Total Current Assets||26,533,033||27,642,506|
|Property and equipment, net||3,531,365||1,295,115|
|Security deposits, non-current||198,674||80,874|
|Operating lease right-of-use asset||1,792,667||1,291,592|
|Liabilities and Stockholders' Equity|
|Accrued expenses and other current liabilities||295,703||503,076|
|Operating lease liabilities - current portion||444,616||484,882|
|Notes payable - current portion, net of debt discount of
|Convertible notes payable - current portion, net of debt discount of
|Total Current Liabilities||6,548,295||4,512,328|
|Operating lease liabilities - non-current portion||1,441,081||907,644|
|Notes payable - non-current portion, net of debt discount of
|Convertible notes payable - non-current portion, net of debt discount of
|Additional paid-in capital||153,299,865||135,461,361|
|Total Stockholders' Equity||15,779,733||17,234,565|
|Total Liabilities and Stockholders' Equity||$||34,865,437||$||31,036,413|
|Condensed Statements of Operations|
|For the Three Months Ended||For the Nine Months Ended|
|Cost of revenue||(1,198||)||-||(1,198||)||-|
|Research and development||3,578,113||3,876,876||8,911,124||11,176,326|
|General and administrative||2,942,073||3,353,352||9,028,768||10,362,907|
|Total Operating Expenses||6,520,186||7,230,228||17,939,892||21,539,233|
|Loss From Operations||(6,520,186||)||(7,230,228||)||(17,939,892||)||(21,539,233||)|
|Other Income (Expense):|
|Other income (expense), net||(348,226||)||70,277||(157,783||)||96,580|
|Total Other Income (Expense)||(818,547||)||(78,768||)||(1,354,067||)||(348,528||)|
|Net Loss Per Share - Basic and Diluted||$||(0.18||)||$||(0.21||)||$||(0.50||)||$||(0.67||)|
|- Basic and Diluted||40,139,697||34,631,774||38,563,074||32,778,551|
Source: Eyenovia, Inc.