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
Eyenovia (NASDAQ: EYEN) reported its Q1 2024 financial results and updates on key products. The company aims to accelerate the development of MicroPine, a late-stage product for pediatric progressive myopia, and anticipates a 3Q 2024 launch for clobetasol propionate ophthalmic suspension, a new steroid for post-ocular surgery inflammation and pain. Additionally, Eyenovia has trained and shipped products to 50 new Mydcombi-using offices since April 2024.
Financially, the company reported a net loss of $10.9 million or $0.23 per share, compared to a $5.7 million loss or $0.15 per share in Q1 2023. Operating expenses increased by 88.1% year-over-year, partly due to reacquiring MicroPine license rights. Eyenovia reduced anticipated cash-based expenses by $0.8 million per quarter and had $8.0 million in cash and equivalents as of March 31, 2024.
The company has completed manufacturing capabilities with FDA approval for three facilities. A conference call and webcast are scheduled for May 15, 2024, at 4:30 pm ET.
- Announcement on accelerating the development of MicroPine for pediatric progressive myopia, potentially addressing a $3 billion market.
- FDA approval of clobetasol propionate ophthalmic suspension 0.05% with a 3Q 2024 launch planned.
- Expansion of Mydcombi distribution, with 50 new offices since April 2024.
- Reduction of anticipated cash-based expenses by $0.8 million per quarter.
- Completed manufacturing capabilities with FDA approval for three facilities.
- Raised an additional $2.2 million in April 2024.
- Net loss increased to $10.9 million in Q1 2024 from $5.7 million in Q1 2023.
- Operating expenses surged by 88.1% year-over-year, reaching $10.3 million.
- Research and development expenses rose by 75.7%, totaling $4.4 million.
- General and administrative expenses increased by 30.6%, amounting to $3.8 million.
- Expenses included $2.5 million related to reacquisition of MicroPine license rights and inventory write-off.
- Unrestricted cash and cash equivalents stood at $8.0 million as of March 31, 2024, which may necessitate additional financing.
Insights
Eyenovia's financial results for the first quarter of 2024 reveal a significant increase in net loss compared to the same period in 2023, jumping from
On the positive side, the company has taken steps to reduce its cash-based expenses by
Upcoming market launches, particularly for Clobetasol and the later-stage MicroPine, will be critical. Investors should keep an eye on sales figures and profitability timelines shared in future reports.
Rating: -1
Eyenovia is positioning itself in the pediatric progressive myopia market, valued at over
Moreover, the launch of Clobetasol in the third quarter of 2024 is significant, given that it will be the first new ophthalmic steroid in 15 years. Its clinical profile—twice-a-day dosing and fewer adverse events—could make it a preferred choice, thus capturing a portion of the ophthalmic steroid market.
The formulary agreements with Vision Source and the University of California are strategic moves that could bolster Mydcombi's market reach and adoption. The expansion into 50 new offices indicates positive market reception and could signal future revenue growth.
Rating: 1
In the realm of medical advancements, Eyenovia's strategy involves leveraging its existing FDA-approved products while focusing on MicroPine's development. The pediatric progressive myopia market is characterized by an unmet need for effective treatments, making MicroPine a potentially transformative solution. This product is anticipated to address a key medical need among the approximately five million at-risk children in the U.S.
Additionally, the approval and planned launch of Clobetasol, an ophthalmic steroid for post-surgical pain, underscores the company's focus on high-need areas. This steroid's twice-a-day dosing and lower adverse-event profile compared to other ocular steroids could enhance patient compliance and outcomes.
The company's investment in R&D, despite increasing expenses, highlights a commitment to innovation. The FDA approval of their manufacturing facilities boosts confidence in their production capabilities, ensuring supply chain reliability for current and future products.
Rating: 1
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
Company to host conference call and webcast today, May 15th, at 4:30 pm ET
NEW YORK, May 15, 2024 (GLOBE NEWSWIRE) -- 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.
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 the U.S. and China. - 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 than2% 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 the University 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.
Michael Rowe, Chief 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.”
“We believe 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.”
“At the same 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.
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 March 31, 2024, the Company’s unrestricted cash and cash equivalents were approximately
Conference Call and Webcast
The conference 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.
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)
PLEASE GO TO CLOBETASOLBID.COM FOR IMPORTANT SAFETY INFORMATION for Clobetasol Proprionate Ophthalmic Suspension
About Eyenovia, Inc.
Eyenovia, 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
Eyenovia 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).
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 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.
Eyenovia Contact:
Eyenovia, Inc.
John Gandolfo
Chief Financial Officer
jgandolfo@eyenovia.com
Eyenovia Investor Contact:
Eric Ribner
LifeSci Advisors, LLC
eric@lifesciadvisors.com
(646) 751-4363
Eyenovia Media Contact:
Eyenovia, Inc.
Norbert Lowe
Vice President, Commercial Operations
nlowe@eyenovia.com
| EYENOVIA, INC. | ||||||||
| 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 | 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 | ||||
| EYENOVIA, INC. | ||||||||
| Condensed Statements of Operations | ||||||||
| (unaudited) | ||||||||
| 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 | ||||||
FAQ
What were Eyenovia's financial results for Q1 2024?
What is the anticipated launch date for clobetasol propionate ophthalmic suspension?
What are Eyenovia's plans for MicroPine?
How much did Eyenovia reduce its cash-based expenses?
What is the current cash position of Eyenovia as of March 31, 2024?
What were the total operating expenses for Eyenovia in Q1 2024?
How many new offices trained and shipped Mydcombi products?
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When is Eyenovia's conference call and webcast scheduled?
