Eyenovia Reports First Quarter 2024 Financial Results and Provides Updates on its Myopia Phase III Program and its Two FDA Approved Commercial Products, Mydcombi and Clobetasol
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Eyenovia Reports First Quarter 2024 Financial Results and Provides Updates on its Myopia Phase III Program and its Two FDA Approved Commercial Products, Mydcombi and Clobetasol
Remains on track towards accelerating development of its late-stage product candidate in the multi-billion-dollar pediatric progressive myopia market, MicroPine
Preparing for a 3Q 2024 launch of the first new ophthalmic steroid in 15 years, clobetasol propionate ophthalmic suspension 0.05%, for the treatment of inflammation and pain following ocular surgery
Company to host conference call and webcast today,
First Quarter 2024 and Recent Business Developments
- Announced updated plans to accelerate development of its late-stage product candidate for pediatric progressive myopia, MicroPine. These plans include a protocol amendment to allow for a Data Monitoring Committee to review the Phase 3 CHAPERONE study data early in the fourth quarter. External sources have valued the pediatric progressive myopia market at over
$3.0 billion annually in theU.S. andChina . - Announced FDA approval of clobetasol propionate ophthalmic suspension 0.05% for the treatment of inflammation and pain following ocular surgery.
Eyenovia is planning a launch of this product in the third quarter of 2024. Clobetasol has a desirable clinical profile as compared to other topical ocular steroids with twice-a-day dosing, a high level of efficacy and with adverse events occurring in fewer than 2% of patients. - Reported training and shipping product to 50 new Mydcombi-using offices by its initial five Key Account Managers since sales promotion started in
April 2024 . Additionally, formulary agreements with Vision Source and theUniversity of California have been executed. - Reduced the Company’s anticipated cash-based expenses by approximately
$0.8 million per quarter from first quarter 2024 actual levels.
“We believe the progress that we continue to make toward optimizing our platform technology has laid a strong foundation towards transforming
“At the same time, we completed the build-out of our manufacturing capabilities, with FDA approval of our
First Quarter 2024 Financial Review
For the first quarter of 2024, net loss was approximately
Research and development expenses totaled approximately
For the first quarter of 2024, general and administrative expenses were approximately
Total operating expenses for the first quarter of 2024 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 here and 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.
PLEASE GO TO MYDCOMBI.COM FOR IMPORTANT SAFETY INFORMATION for MYDCOMBI™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5%
PLEASE GO TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for Clobetasol Proprionate Ophthalmic Suspension 0.05%
About Eyenovia, Inc.
For more information, visit Eyenovia.com.
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; 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
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 Sheet | ||||||||
| 2024 | 2023 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 7,976,106 | $ | 14,849,057 | ||||
| Inventories | 3,513,860 | 109,798 | ||||||
| Deferred clinical supply costs | 846,301 | 4,256,793 | ||||||
| License fee and expense reimbursements receivable | 88,045 | 123,833 | ||||||
| Security deposits, current | 1,506 | 1,506 | ||||||
| Prepaid expenses and other current assets | 2,025,267 | 1,365,731 | ||||||
| Total Current Assets | 14,451,085 | 20,706,718 | ||||||
| Property and equipment, net | 3,155,710 | 3,374,384 | ||||||
| Security deposits, non-current | 197,168 | 197,168 | ||||||
| Intangible assets | 6,122,945 | 2,122,945 | ||||||
| Operating lease right-of-use asset | 1,538,814 | 1,666,718 | ||||||
| Equipment deposits | 711,441 | 711,441 | ||||||
| Total Assets | $ | 26,177,163 | $ | 28,779,374 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 2,145,272 | $ | 1,753,172 | ||||
| Accrued compensation | 828,286 | 1,658,613 | ||||||
| Accrued expenses and other current liabilities | 4,751,755 | 287,928 | ||||||
| Operating lease liabilities - current portion | 579,585 | 501,250 | ||||||
| Notes payable - current portion, net of debt discount of |
8,155,025 | 5,329,419 | ||||||
| Total Current Liabilities | 16,459,923 | 9,530,382 | ||||||
| Operating lease liabilities - non-current portion | 1,140,231 | 1,292,667 | ||||||
| Notes payable - non-current portion, net of debt discount of |
2,103,456 | 4,355,800 | ||||||
| Convertible notes payable - net of debt discount of |
4,655,781 | 4,601,431 | ||||||
| Total Liabilities | 24,359,391 | 19,780,280 | ||||||
| Stockholders' Equity: | ||||||||
| Preferred stock, |
||||||||
| Common stock, |
4,738 | 4,555 | ||||||
| Additional paid-in capital | 158,226,694 | 154,486,098 | ||||||
| Accumulated deficit | (156,413,660 | ) | (145,491,559 | ) | ||||
| Total Stockholders' Equity | 1,817,772 | 8,999,094 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 26,177,163 | $ | 28,779,374 | ||||
| Condensed Statements of Operations | ||||||||
| (unaudited) | ||||||||
| For the Three Months Ended | ||||||||
| 2024 | 2023 | |||||||
| Operating Income | ||||||||
| Revenue | $ | 4,993 | $ | - | ||||
| Cost of revenue | (4,993 | ) | - | |||||
| Gross Profit | - | - | ||||||
| Operating Expenses: | ||||||||
| Research and development | 4,431,601 | 2,521,950 | ||||||
| General and administrative | 3,835,223 | 2,936,886 | ||||||
| Reacquisition of license rights | 2,000,000 | - | ||||||
| Total Operating Expenses | 10,266,824 | 5,458,836 | ||||||
| Loss From Operations | (10,266,824 | ) | (5,458,836 | ) | ||||
| Other Income (Expense): | ||||||||
| Other (expense) income, net | (97,558 | ) | 70,993 | |||||
| Interest expense | (678,658 | ) | (454,003 | ) | ||||
| Interest income | 120,939 | 102,480 | ||||||
| Total Other Expense | (655,277 | ) | (280,530 | ) | ||||
| Net Loss | $ | (10,922,101 | ) | $ | (5,739,366 | ) | ||
| Net Loss Per Share - Basic and Diluted | $ | (0.23 | ) | $ | (0.15 | ) | ||
| Shares Outstanding - Basic and Diluted | 46,606,790 | 37,410,587 | ||||||
Source: Eyenovia, Inc.