Full Press Release Details
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
towards accelerating development of its late-stage product candidate in the multi-billion-dollar pediatric progressive myopia market,
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
conference call and webcast today, May 15th, at 4:30 pm ET
15, 2024-Eyenovia, Inc. (NASDAQ: EYEN), a commercial-stage ophthalmic company with two FDA-approved products and a late-stage asset
in pediatric progressive myopia, today announced its financial and operating results for the first quarter ended March 31, 2024.
2024 and Recent Business Developments
Executive Officer, commented, "During the first quarter of 2024, we took tangible steps to increase the inherent value of our company,
which currently includes our novel Optejet technology, two FDA-approved products, and a third in late Phase 3 development. With highly
differentiated and desirable products such as Mydcombi for mydriasis and clobetasol for post-surgical pain and inflammation, we look
forward to meaningful sales growth over the next 18 months that we anticipate will lead us towards profitability. And our crown jewel,
MicroPine for progressive myopia, if approved, would add significant value to the company by addressing a key unmet medical need of the
approximately five million at-risk children in the U.S. alone."
the progress that we continue to make toward optimizing our platform technology has laid a strong foundation towards transforming Eyenovia
into a leader in the development and commercialization of topical ophthalmic products and medications. We are committed to demonstrating
the value of our existing and near-term products as well as future product candidates in ophthalmic markets with high unmet needs."
time, we completed the build-out of our manufacturing capabilities, with FDA approval of our Redwood City location in addition to our
Reno facility and Coastline International as our contract manufacturer. With all three facilities online, we are currently producing
commercial supply of Mydcombi while at the same time supporting both current and future development partnerships as well as our transition
from the Gen-1 to Gen-2 Optejet dispenser. To that end, we recently requested a meeting with the FDA to discuss our validation of the
Gen-2 dispenser, which we anticipate will occur this summer," Mr. Rowe concluded.
2024 Financial Review
For the first quarter
of 2024, net loss was approximately $10.9 million, or $0.23 per share, as compared to a net loss of $5.7 million, or $0.15 per share,
for the first quarter of 2023. The first quarter 2024 net loss includes $2.5 million of expense, or $0.05 loss per share, associated
with the reacquisition of the license rights from Bausch for MicroPine and the write off of related clinical trial inventory.
Research and development
expenses totaled approximately $4.4 million for the first quarter of 2024, compared to $2.5 million for the first quarter of 2023, an
increase of approximately 75.7%.
For the first quarter
of 2024, general and administrative expenses were approximately $3.8 million, compared to $2.9 million for the first quarter of 2023,
an increase of approximately 30.6%.
expenses for the first quarter of 2024 were approximately $10.3 million, including the previously referenced $2.5 million of expenses
associated with the Bausch transaction, compared to approximately $5.5 million for the first quarter of 2023. This represents an increase
of approximately 88.1%. The first quarter 2024 operating expense figure includes approximately $1.5 million of non-cash expenses.
2024, the Company's unrestricted cash and cash equivalents were approximately $8.0 million, not including $2.2 million in additional
capital the Company raised in April 2024.
call is scheduled to begin at 4:30 pm ET today, May 15th. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470
(international), and reference conference ID 13746269.
me feature, which avoids having to wait for an operator, click here.
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.
TO MYDCOMBI.COM FOR IMPORTANT SAFETY INFORMATION for MYDCOMBI (tropicamide and phenylephrine hydrochloride ophthalmic spray)
TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for Clobetasol Proprionate Ophthalmic Suspension 0.05%
Inc. (NASDAQ: EYEN) is a commercial-stage ophthalmic pharmaceutical technology company developing a pipeline of microdose array print
therapeutics based on its Optejet platform. Eyenovia is currently focused on the commercialization of Mydcombi (tropicamide+phenylephrine
ophthalmic spray) for mydriasis, as well as clobetasol propionate ophthalmic nanosuspension 0.05% to reduce pain and inflammation following
ocular surgery, which was approved by the FDA on March 4, 2024.
is also advancing late-stage development of medications in the Optejet device for presbyopia (Apersure) and myopia progression (MicroPine,
partnered with Arctic Vision in China and South Korea).
more information, visit Eyenovia.com.
Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.
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 U.S. Securities and Exchange Commission, including those described in our Annual Report on Form 10-K as well as
our Quarterly Reports on Form 10-Q, and supplemented from time to time by our Current Reports on Form 8-K. Any forward-looking statements
speak only as of the date on which they are made, and except as may be required under applicable securities laws, Eyenovia does not undertake
any obligation to update any forward-looking statements.
Chief Financial Officer
LifeSci Advisors, LLC
Commercial Operations
Condensed Balance Sheet
| March 31, | December 31, | |||||||
| 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 $621,712 and $503,914 as of March 31, 2024 and December 31, 2023, respectively | 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 $200,711 and $448,367 as of March 31, 2024 and December 31, 2023, respectively | 2,103,456 | 4,355,800 | ||||||
| Convertible notes payable - net of debt discount of $344,219 and $398,569 as of March 31, 2024 and December 31, 2023, respectively | 4,655,781 | 4,601,431 | ||||||
| Total Liabilities | 24,359,391 | 19,780,280 | ||||||
| Stockholders' Equity: | ||||||||
| Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2024 and December 31, 2023 | ||||||||
| Common stock, $0.0001 par value, 90,000,000 shares authorized; 47,386,349 and 45,553,026 shares issued and outstanding as of March 31, 2024 and December 31, 2023, respectively | 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
| For the Three Months Ended | ||||||||
| March 31, | ||||||||
| 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 |