Full Press Release Details
Eyenovia Reports First Quarter 2023 Financial
Results and Provides Business Update
FDA approval of Mydcombi , a fixed dose combination of tropicamide and phenylephrine for mydriasis, the first FDA approved product
to utilize the Optejet
Received feedback from FDA on its Phase 3 Microline
presbyopia candidate that provides a clear and efficient path forward for the program
Entered into co-development agreement with Formosa
Pharmaceuticals for the potential development of new topical ophthalmic therapeutics
Company to host conference call and webcast
today, May 11, at 4:30 pm ET
YORK-May 11, 2023-Eyenovia, Inc. (NASDAQ: EYEN), an ophthalmic technology company developing the Optejet
delivery system for use both in combination with its own drug-device therapeutic programs for mydriasis, presbyopia and pediatric progressive
myopia as well as out-licensing for additional indications, today announced its financial and operating results for the first quarter
ended March 31, 2023.
First Quarter 2023 and Recent Business Developments
Michael Rowe, Chief Executive Officer, commented,
"We are proud to be delivering on our commitments in 2023 with the recently announced FDA approval of Mydcombi, our first approved
product dispensed using our Optejet technology. We believe the Optejet will transform the way that topical eye drugs are developed and
delivered, and this FDA approval marks a significant milestone in its evolution. It is also an important achievement in the context of
our current and future partnerships, providing a template for the development of additional ophthalmic therapies administered via the
Optejet in high-value ophthalmic indications."
"Regarding our pre-NDA Microline program
for presbyopia, we received clear feedback from the FDA that provides an efficient path forward for the program. We are in the process
of completing the build-out and validation of our Redwood City manufacturing facility and remain on track to commence the manufacture
of launch batches early next year. In the interim, we plan to conduct supportive human factors testing and clinical work demonstrating
the usability of the Gen-2 Optejet device, which has been optimized for in-home use."
"With one product approved, and line-of-sight
toward a second, we have reached a true inflection point in the evolution of our company. Having an FDA approved product not only provides
critical validation of our Optejet technology for our own advanced clinical programs, but also our partnerships as well. To that end,
we continue to advance discussions with additional partners that could potentially assess the utility of Optejet in very large indications
such as glaucoma and dry eye, among others. I am pleased with our progress to date and look forward to initial commercial sales of Mydcombi
this summer together with continued clinical and regulatory progress for us and our partners."
First Quarter 2023 Financial Review
For the first quarter of 2023, net loss was approximately
$(5.7) million, or $(0.15) per share compared to a net loss of approximately $(7.3) million, or $(0.24) per share, for the first quarter
Research and development expenses totaled approximately
$2.5 million for the first quarter of 2023 as compared to $3.7 million for the first quarter of 2022.
For the first quarter of 2023, general and administrative
expenses were approximately $2.9 million, compared to $3.5 million for the first quarter of 2022.
Total operating expenses for the first quarter
of 2023 were approximately $5.5 million compared to $7.2 million for the first quarter of 2022.
As of March 31, 2023, the Company's
cash and cash equivalents were approximately $18.5 million compared to $22.9 million as of December 31, 2022. In addition, with the
approval of Mydcombi, the Company has the ability to draw down an additional $5 million on its credit facility with Avenue Capital before
Conference Call and Webcast
conference call is scheduled to begin at 4:30 pm ET today, May 11. Participants should dial 1-877-407-9039 (domestic) or 1-201-689-8470
(international). 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.
access the Call me feature, which avoids having to wait for an operator, click here.
After the live webcast, the event will be archived
on Eyenovia's website for one year.
About Eyenovia, Inc.
Eyenovia, Inc. (NASDAQ:
EYEN) is an ophthalmic pharmaceutical technology company developing a pipeline of microdose array print therapeutics. Eyenovia is
currently focused on the commercialization of Mydcombi and the late-stage development of microdosed medications for presbyopia and myopia
progression. For more information, visit www.eyenovia.com.
Eyenovia Corporate Information slide deck may be found at ir.eyenovia.com/events-and-presentations.
Chief Financial Officer
LifeSci Advisors, LLC
Vice President, Commercial Operations
Condensed Balance Sheets
| March 31, | December 31, | |||||||
| 2023 | 2022 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current Assets: | ||||||||
| Cash and cash equivalents | $ | 18,466,322 | $ | 22,863,520 | ||||
| Deferred clinical supply costs | 3,352,645 | 2,284,931 | ||||||
| License fee and expense reimbursements receivable | 973,677 | 1,183,786 | ||||||
| Security deposits, current | 119,550 | 119,550 | ||||||
| Prepaid expenses and other current assets | 2,011,884 | 1,190,719 | ||||||
| Total Current Assets | 24,924,078 | 27,642,506 | ||||||
| Property and equipment, net | 2,152,861 | 1,295,115 | ||||||
| Security deposits, non-current | 80,874 | 80,874 | ||||||
| Operating lease right-of-use asset | 1,508,158 | 1,291,592 | ||||||
| Equipment deposits | 643,513 | 726,326 | ||||||
| Total Assets | $ | 29,309,484 | $ | 31,036,413 | ||||
| Liabilities and Stockholders' Equity | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | 1,402,076 | $ | 1,428,283 | ||||
| Accrued compensation | 637,189 | 1,747,191 | ||||||
| Accrued expenses and other current liabilities | 460,143 | 503,076 | ||||||
| Operating lease liabilities - current portion | 472,901 | 484,882 | ||||||
| Notes payable - current portion, net of debt discount of $123,480 and $33,885 as of March 31, 2023 and December 31, 2022, respectively | 1,218,963 | 174,448 | ||||||
| Convertible notes payable - current portion, net of debt discount of $123,480 and $33,885 as of March 31, 2023 and December 31, 2022, respectively | 709,853 | 174,448 | ||||||
| Total Current Liabilities | 4,901,125 | 4,512,328 | ||||||
| Operating lease liabilities - non-current portion | 1,133,948 | 907,644 | ||||||
| Notes payable - non-current portion, net of debt discount of $648,889 and $813,229 as of March 31, 2023 and December 31, 2022, respectively | 3,730,278 | 4,190,938 | ||||||
| Convertible notes payable - non-current portion, net of debt discount of $648,889 and $813,229 as of March 31, 2023 and December 31, 2022, respectively | 3,730,278 | 4,190,938 | ||||||
| Total Liabilities | 13,495,629 | 13,801,848 | ||||||
| Stockholders' Equity: | ||||||||
| Preferred stock, $0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of March 31, 2023 and December 31, 2022 | - | - | ||||||
| Common stock, $0.0001 par value, 90,000,000 shares authorized; 37,991,746 and 36,668,980 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 3,799 | 3,667 | ||||||
| Additional paid-in capital | 139,779,885 | 135,461,361 | ||||||
| Accumulated deficit | (123,969,829 | ) | (118,230,463 | ) | ||||
| Total Stockholders' Equity | 15,813,855 | 17,234,565 | ||||||
| Total Liabilities and Stockholders' Equity | $ | 29,309,484 | $ | 31,036,413 |
Condensed Statements of Operations
| For the Three Months Ended March 31, | ||||||||
| 2023 | 2022 | |||||||
| Operating Expenses: | ||||||||
| Research and development | $ | 2,521,950 | $ | 3,712,584 | ||||
| General and administrative | 2,936,886 | 3,474,965 | ||||||
| Total Operating Expenses | 5,458,836 | 7,187,549 | ||||||
| Loss From Operations | (5,458,836 | ) | (7,187,549 | ) | ||||
| Other Income (Expense): | ||||||||
| Other income (expense), net | 70,993 | (7,073 | ) | |||||
| Interest expense | (454,003 | ) | (145,237 | ) | ||||
| Interest income | 102,480 | 194 | ||||||
| Net Loss | $ | (5,739,366 | ) | $ | (7,339,665 | ) | ||
| Net Loss Per Share - Basic and Diluted | $ | (0.15 | ) | $ | (0.24 | ) | ||
| Weighted Average Number of Common Shares Outstanding | ||||||||
| - Basic and Diluted | 37,410,587 | 30,008,194 |