Eyenovia Announces Q2 2024 Financial Results and Corporate Update

Eyenovia, Inc., a commercial-stage ophthalmic company listed on NASDAQ (ticker: EYEN), has reported significant progress in its second-quarter financial and operational activities. Notable advancements were made in the development of their Gen-2 Optejet® device, the Phase 3 CHAPERONE study of MicroPine for pediatric progressive myopia, and various commercial and collaborative initiatives.

Following a pivotal FDA meeting in July, Eyenovia has announced plans to validate and commence production of the Gen-2 Optejet device by Q4 2024, with regulatory submission planned for 2025. The Gen-2 Optejet is designed to be user-friendly and cost-efficient, aiming to reduce the monthly cartridge cost to $20. Mydcombi™ will be the first product submitted using this advanced technology.

The company is also making headway in its Phase 3 CHAPERONE study for MicroPine, targeting pediatric progressive myopia. This market is valued at over $3 billion annually in the U.S. and China. Data analysis for this study is slated for the fourth quarter of 2024, which could expedite the product’s development.

In the sales domain, Eyenovia has been proactive, training and shipping Mydcombi to 63 new offices from April through June 30, 2024, with the aim of expanding to 263 offices by the end of the third quarter. Additionally, the company is preparing for the launch of clobetasol propionate ophthalmic suspension 0.05%, the first new ophthalmic steroid to enter the market in 15 years.

Strategic partnerships have also been a focus, with newly announced collaborations with Formosa Pharmaceuticals, Senju Pharmaceutical Co., Ltd., and SGN Nanopharma. These partnerships aim to leverage Eyenovia's Optejet technology to develop treatments for dry eye disease, a market estimated at $5 billion globally.

Financially, Eyenovia completed an equity placement with two of its largest shareholders. This financial boost is expected to support operations through the Phase 3 CHAPERONE data release.

CEO Michael Rowe highlighted the company's successful advancements in commercial initiatives and co-development agreements that target unmet needs in multi-billion-dollar markets. The Gen-2 Optejet device is on track for a 2025 submission, and the Mydcombi product has been well-received, expanding its reach to new ophthalmic offices.

Regarding MicroPine, Rowe noted that preparations are underway for the Phase 3 data analysis, which could significantly accelerate its development. The company has also completed several agreements to explore novel therapeutics for dry eye disease using the Optejet dispenser.

The financial review for Q2 2024 revealed a net loss of approximately $11.1 million, or $0.21 per share, compared to a $6.2 million loss in Q2 2023. The increased loss includes $2.9 million expenses related to reacquiring MicroPine license rights from Bausch + Lomb. Revenue write-offs and gains in fair value changes from transactions with Bausch + Lomb and Formosa were also noted.

Research and development expenses rose to $4.6 million due to clinical expenses from reacquiring MicroPine rights, while general and administrative expenses increased to $3.8 million, reflecting the establishment of Eyenovia’s sales force.

Eyenovia’s unrestricted cash and cash equivalents stood at approximately $2.3 million as of June 30, 2024, excluding $5.8 million in gross proceeds from equity offerings completed afterward.

Eyenovia remains committed to enhancing its value proposition, supported by a portfolio that includes two FDA-approved products and a promising third in late Phase 3 development. The company continues to explore opportunities within large market indications leveraging its novel Optejet technology.

In summary, Eyenovia is well-positioned to be a significant partner to ophthalmic offices, addressing diverse physician and patient needs with its innovative products.