Core Viewpoint - Eyenovia, Inc. reported a quarterly loss of $0.18 per share, slightly worse than the Zacks Consensus Estimate of a loss of $0.17, indicating a negative earnings surprise of -5.88% [1] Financial Performance - The company posted revenues of $0.02 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 98.33%, compared to zero revenues a year ago [2] - Over the last four quarters, Eyenovia has surpassed consensus EPS estimates only once [2] Stock Performance - Eyenovia shares have declined approximately 58.7% since the beginning of the year, contrasting with the S&P 500's gain of 12% [3] - The current consensus EPS estimate for the upcoming quarter is -$0.18 on revenues of $1.6 million, and for the current fiscal year, it is -$0.76 on revenues of $5.03 million [7] Industry Outlook - The Medical - Biomedical and Genetics industry, to which Eyenovia belongs, is currently ranked in the top 30% of over 250 Zacks industries, suggesting a favorable outlook compared to lower-ranked industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Eyenovia's stock performance [5]

Following FDA consultation, announced plans for validation of the Gen-2 Optejet® device and 2025 regulatory submission with Mydcombi™ as lead product Advanced Phase 3 CHAPERONE study of MicroPine as a treatment of pediatric progressive myopia with preparations for analysis in Q4 Commenced sales activities with focus on Mydcombi in 260+ offices and preparations for launch of clobetasol propionate ophthalmic suspension 0.05%, the first new ophthalmic steroid to enter the market in 15 years Announced developme ...

NEW YORK, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercialstage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced that it has signed a non-binding agreement with Taiwan-based Formosa Pharmaceuticals (TWO:6838) whereby the companies will co-develop a formulation of clobetasol propionate ophthalmic suspension 0.05% ("clobetasol propionate") in combination with the Optejet device for the shortterm relief of dry ...

NEW YORK, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Eyenovia, Inc. (NASDAQ: EYEN), a commercialstage ophthalmic company with two FDA-approved products and a late-stage asset in pediatric progressive myopia, today announced that it has signed a non-binding agreement with Taiwan-based Formosa Pharmaceuticals (TWO:6838) whereby the companies will co-develop a formulation of clobetasol propionate ophthalmic suspension 0.05% ("clobetasol propionate") in combination with the Optejet device for the shortterm relief of dry ...

Eyenovia, Inc. is an ophthalmic technology company commercializing Mydcombi™ (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1%/2.5% for mydriasis, Clobetasol Propionate Ophthalmic Suspension, 0.05% for postsurgical inflammation and pain, and developing the Optejet® device for use both in connection with its own drug-device therapeutic product for pediatric progressive myopia as well as outlicensing for additional indications. For more information, please visit Eyenovia.com. Except for histor ...

Chardan is acting as the lead-placement agent for the Offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, is also acting as a co-placement agent for the Offering. The gross proceeds to Eyenovia from this Offering are expected to be approximately $5 million, before deducting the placement agents' fees and other offering expenses payable by Eyenovia. Eyenovia intends to use the net proceeds from this Offering to fund commercialization activities for Mydcombi and clobetasol propionate, ...

Eyenovia, Inc. (EYEN) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate. Since a changing earnings ...

Financial Data and Key Metrics Changes - For the first quarter of 2024, the company reported a net loss of approximately $10.9 million or $0.23 per share, compared to a net loss of $5.7 million or $0.15 per share in the first quarter of 2023 [64][94] - General and administrative expenses increased by 30.6% to approximately $3.8 million compared to $2.9 million in the first quarter of 2023 [65] - Total operating expenses for the first quarter of 2024 were approximately $10.3 million, an increase of approximately 88% from $5.5 million in the same period in 2023 [65] Business Line Data and Key Metrics Changes - The company is focusing on the successful commercialization of MydCombi and clobetasol, with a potential blockbuster MicroPine in late Phase III development [40][45] - Clobetasol was approved by the FDA on March 4, 2024, and is expected to capture a mid-single-digit market share in a $1.3 billion annual market for topical ocular steroids [31][46] - The sales force has been trained and is making inroads into the market, having converted about 50 offices to date [34][51] Market Data and Key Metrics Changes - The U.S. market for pediatric progressive myopia is estimated at $1.8 billion annually, with a similar opportunity in China [24] - The dry eye market is valued at approximately $3.6 billion annually in the U.S., presenting a significant opportunity for the company [33] - The company has entered into a collaboration agreement with SGN Nanopharma to develop a treatment for chronic dry eye, potentially leading to a Phase III-ready asset next year [32][50] Company Strategy and Development Direction - The company aims to establish a solid foundation for its portfolio with a second FDA-approved product to be launched soon and a focus on the expedited development of MicroPine [40][68] - The strategy includes reducing planned spending by approximately $800,000 per quarter and focusing resources on validating the Gen 2 device with the FDA and commercializing Mydcombi and clobetasol [66][96] - The company is exploring various options to ensure sufficient capital to support its growth strategy [121] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the potential of MicroPine, which could be a significant source of non-dilutive funding if approved [67] - The company is optimistic about the upcoming FDA meeting regarding the Gen 2 device, which is expected to lead to market readiness by the end of next year [70][117] - Management highlighted the importance of the Optejet technology in differentiating their products in the market [74] Other Important Information - The company has generated approximately $16 million in license fees from its agreements and has the potential to earn an additional $25 million in non-dilutive net license and development milestones [67] - The company has participated in several national ophthalmology medical meetings to raise awareness of its product portfolio [69][86] Q&A Session Summary Question: Can you talk about the transition to the Gen 2 device? - The company plans to submit for an FDA meeting in mid-July and expects to make Gen 2 supply shortly thereafter, with a small bridging study to follow [70][101] Question: How does the company view the competition in the eye drop market? - The company believes that the Optejet device offers significant differentiation, as it is preferred by potential users for its convenience and ease of use [74] Question: What is the status of the Gen 2 device and its relevance to current products? - The Gen 2 device will be the only platform moving forward, and its validation against Mydcombi will be crucial for all other programs [107][112] Question: How is the company managing its cash runway? - The company has reduced spending and is exploring various options to ensure sufficient capital to support its growth strategy [121] Question: What are the expectations for the upcoming FDA approval for clobetasol? - The company is preparing for a robust commercial launch of clobetasol later in the summer and sees potential for further development of formulations for acute dry eye [78][98]

Exhibit 99.1 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 inflammat ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended: March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to COMMISSION FILE NUMBER: 001-38365 EYENOVIA, INC. (Exact name of Registrant as Specified in Its Charter) | DELAWARE | | 47-1178401 | | --- | --- | --- ...