Eyenovia Reports Second Quarter 2023 Financial Results and Provides Business Update
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Eyenovia Reports Second Quarter 2023 Financial Results and Provides Business Update
Announced FDA approval of and first commercial sale of Mydcombi™, the only fixed dose combination of tropicamide and phenylephrine for mydriasis and the first FDA approved product to utilize the Optejet®
Continued to advance its Phase 3 Apersure™ (Microline) presbyopia candidate following receipt of guidance from FDA that establishes an efficient path forward for the program
Company to host conference call and webcast today,
Second Quarter 2023 and Recent Business Developments
- Announced first commercial sale of Mydcombi to world-renowned board-certified ophthalmologist Dr.
Nathan M. Radcliffe , who becomes first to incorporate Mydcombi into his daily practice. The company will be following up with sales to key physicians in the upcoming weeks and preparing for national launch in early 2024. - Advanced its pre-NDA presbyopia program, Apersure (Microline), and anticipates commencing the manufacture of registration batches in the fourth quarter of 2023.
- Continued to build out its manufacturing facilities in
Redwood City, CA andReno, NV , the former having a PDUFA date inNovember 2023 for use as a commercial facility. - Delivered presentation at the annual
OCTANE Ophthalmology Tech Forum 2023 reviewing the recent FDA approval of Mydcombi. - Licensing partners Bausch+Lomb and Arctic Vision continued to enroll patients in their respective Phase 3 studies of Micropine (US and
China ) and Microline (China ). - Announced addition to widely followed Russell 2000 and Russell 3000 Indexes.
"Regarding our pre-NDA presbyopia candidate, Apersure, we continue to advance this important program following receipt of feedback from FDA that established a clear and efficient path forward. The addressable presbyopia market for topical ophthalmic medications is a nearly
“We believe the approval and commercial availability of Mydcombi will fundamentally transform the way that topical eye drugs are developed and delivered, as we now have critical validation of our Optejet platform that will benefit not only our proprietary development programs, most notably Apersure, but current and future partnerships as well. To that end, we continue to have very productive discussions with potential partners that could ultimately see the Optejet incorporated into additional large market ophthalmology indications with persistent unmet needs.
“I am extremely pleased with our progress to date and look forward to a productive back half of the year,”
Second Quarter 2023 Financial Review
For the second quarter of 2023, net loss was approximately
Research and development expenses totaled approximately
For the second quarter of 2023, general and administrative expenses were approximately
Total operating expenses for the second quarter of 2023 were approximately
As of
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%
INDICATIONS
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.
DRUG INTERACTIONS
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
ADVERSE REACTIONS
- 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.
The Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.
Forward-Looking Statements
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; 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
Eyenovia Contact:
Chief Financial Officer
jgandolfo@eyenovia.com
Eyenovia Investor Contact:
eric@lifesciadvisors.com
(646) 751-4363
Eyenovia Media Contact:
Vice President, Commercial Operations
nlowe@eyenovia.com
| Condensed Balance Sheets | |||||||||||
| |
|||||||||||
| 2023 | 2022 | ||||||||||
| (unaudited) | |||||||||||
| Assets | |||||||||||
| = | |||||||||||
| Current Assets | |||||||||||
| Cash and cash equivalents | $ | 17,468,088 | $ | 22,863,520 | |||||||
| Deferred clinical supply costs | 3,578,326 | 2,284,931 | |||||||||
| License fee and expense reimbursements receivable | 429,006 | 1,183,786 | |||||||||
| Security deposits, current | - | 119,550 | |||||||||
| Prepaid expenses and other current assets | 1,801,373 | 1,190,719 | |||||||||
| Total Current Assets | 23,276,793 | 27,642,506 | |||||||||
| Property and equipment, net | 3,698,421 | 1,295,115 | |||||||||
| Security deposits, non-current | 198,674 | 80,874 | |||||||||
| Operating lease right-of-use asset | 1,915,061 | 1,291,592 | |||||||||
| Equipment deposits | 257,950 | 726,326 | |||||||||
| Total Assets | $ | 29,346,899 | $ | 31,036,413 | |||||||
| Liabilities and Stockholders' Equity | |||||||||||
| Current Liabilities: | |||||||||||
| Accounts payable | $ | 1,312,749 | $ | 1,428,283 | |||||||
| Accrued compensation | 1,013,118 | 1,747,191 | |||||||||
| Accrued expenses and other current liabilities | 363,431 | 503,076 | |||||||||
| Operating lease liabilities - current portion | 427,749 | 484,882 | |||||||||
| Notes payable - current portion, net of debt discount of |
|||||||||||
| and |
947,163 | 174,448 | |||||||||
| Convertible notes payable - current portion, net of debt discount of |
|||||||||||
| and |
- | 174,448 | |||||||||
| Total Current Liabilities | 4,064,210 | 4,512,328 | |||||||||
| Operating lease liabilities - non-current portion | 1,584,218 | 907,644 | |||||||||
| Notes payable - non-current portion, net of debt discount of |
|||||||||||
| and |
8,683,794 | 4,190,938 | |||||||||
| Convertible notes payable - non-current portion, net of debt discount of |
|||||||||||
| and |
4,492,730 | 4,190,938 | |||||||||
| Total Liabilities | 18,824,952 | 13,801,848 | |||||||||
| Stockholders' Equity: | |||||||||||
| Preferred stock, |
|||||||||||
| 0 shares issued and outstanding as of |
|||||||||||
| - | - | ||||||||||
| Common stock, |
|||||||||||
| 38,169,398 and 36,668,980 shares issued and outstanding | |||||||||||
| as of |
3,817 | 3,667 | |||||||||
| Additional paid-in capital | 140,703,819 | 135,461,361 | |||||||||
| Accumulated deficit | (130,185,689 | ) | (118,230,463 | ) | |||||||
| Total Stockholders' Equity | 10,521,947 | 17,234,565 | |||||||||
| Total Liabilities and Stockholders' Equity | $ | 29,346,899 | $ | 31,036,413 | |||||||
| Condensed Statements of Operations | |||||||||||||||||
| (unaudited) | |||||||||||||||||
| For the Three Months Ended | For the Six Months Ended | ||||||||||||||||
| |
|
||||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||||
| Operating Expenses: | |||||||||||||||||
| Research and development | $ | 2,811,061 | $ | 3,586,866 | $ | 5,333,011 | $ | 7,299,450 | |||||||||
| General and administrative | 3,149,809 | 3,534,590 | 6,086,695 | 7,009,555 | |||||||||||||
| Total Operating Expenses | 5,960,870 | 7,121,456 | 11,419,706 | 14,309,005 | |||||||||||||
| Loss From Operations | (5,960,870 | ) | (7,121,456 | ) | (11,419,706 | ) | (14,309,005 | ) | |||||||||
| Other Income (Expense): | |||||||||||||||||
| Other income, net | 119,450 | 33,376 | 190,443 | 26,303 | |||||||||||||
| Interest expense | (558,003 | ) | (153,436 | ) | (1,012,006 | ) | (298,673 | ) | |||||||||
| Interest income | 183,563 | 2,416 | 286,043 | 2,610 | |||||||||||||
| Net Loss | $ | (6,215,860 | ) | $ | (7,239,100 | ) | $ | (11,955,226 | ) | $ | (14,578,765 | ) | |||||
| Net Loss Per Share - Basic and Diluted | $ | (0.16 | ) | $ | (0.22 | ) | $ | (0.32 | ) | $ | (0.46 | ) | |||||
| Weighted Average Number of Common | |||||||||||||||||
| Shares Outstanding | |||||||||||||||||
| - Basic and Diluted | 38,093,826 | 33,644,867 | 37,753,694 | 31,836,582 | |||||||||||||
Source: Eyenovia, Inc.