Eyenovia Q1 2024 Financial Results and Updates on Myopia Program and FDA-Approved Products

Eyenovia, Inc., a New York-based ophthalmic company (NASDAQ: EYEN), has shared its financial and operational results for the first quarter of 2024. This update highlights significant developments, including the progress of its late-stage product candidate for pediatric progressive myopia, MicroPine, and the anticipated launch of clobetasol propionate ophthalmic suspension 0.05% in the third quarter of 2024.

In the first quarter, the company outlined plans to expedite the development of MicroPine, which aims to address pediatric progressive myopia. This condition affects millions of children in the U.S. and China, a market valued at over $3 billion annually. To accelerate this process, Eyenovia has amended the protocol of its Phase 3 CHAPERONE study to allow the Data Monitoring Committee to review the study data early in the fourth quarter.

The FDA has approved clobetasol propionate ophthalmic suspension 0.05% for treating inflammation and pain following ocular surgery. This marks the first new ophthalmic steroid in 15 years, featuring a twice-daily dosing regimen, high efficacy, and adverse events in less than 2% of patients. Eyenovia plans to launch this product in the third quarter of 2024.

Additionally, the company reported the training and shipment of Mydcombi products to 50 new offices, facilitated by its initial five Key Account Managers since April 2024. Eyenovia has also secured formulary agreements with Vision Source and the University of California, further expanding its market reach.

Financially, Eyenovia managed to reduce cash-based expenses by approximately $0.8 million per quarter from first-quarter levels. Despite these savings, the company recorded a net loss of $10.9 million, or $0.23 per share, for the first quarter of 2024, compared to a net loss of $5.7 million, or $0.15 per share, for the same period in 2023. This increase includes $2.5 million in expenses related to reacquiring license rights from Bausch for MicroPine and the write-off of associated clinical trial inventory.

Research and development expenses rose by approximately 75.7%, totaling $4.4 million for the first quarter of 2024, up from $2.5 million in the same period of 2023. General and administrative expenses increased by 30.6%, amounting to $3.8 million compared to $2.9 million in the first quarter of 2023. Overall operating expenses for the first quarter of 2024 were approximately $10.3 million, an 88.1% increase from the previous year's $5.5 million, including $1.5 million in non-cash expenses.

As of March 31, 2024, Eyenovia's unrestricted cash and cash equivalents stood at approximately $8.0 million. Additionally, the company raised $2.2 million in capital in April 2024.

CEO Michael Rowe highlighted the company's achievements in enhancing its inherent value, emphasizing the potential of its Optejet technology and FDA-approved products, Mydcombi and clobetasol. He expressed optimism about achieving profitability within the next 18 months, driven by meaningful sales growth. Rowe also noted that MicroPine, if approved, would significantly boost the company's value by addressing a crucial unmet medical need among five million at-risk children in the U.S. alone.

Eyenovia has also completed the build-out of its manufacturing capabilities, receiving FDA approval for its Redwood City location alongside existing facilities in Reno and Coastline International. With these facilities operational, the company is producing commercial supplies of Mydcombi and supporting both current and future development partnerships. Eyenovia is transitioning from its Gen-1 to Gen-2 Optejet dispenser and has requested a meeting with the FDA to discuss Gen-2 validation, anticipated to occur this summer.

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