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. The company currently has two FDA-approved products, MydCombi and clobetasol propionate ophthalmic suspension 0.05%, and a late-stage asset in pediatric progressive myopia, MicroPine.

In the first quarter of 2024, Eyenovia reported a net loss of $10.9 million, or $0.23 per share, on approximately 46.6 million weighted average shares outstanding. This compares to a net loss of $5.7 million, or $0.15 per share, on approximately 37.4 million weighted average shares outstanding in the first quarter of 2023. The increase in net loss was primarily driven by higher research and development expenses, general and administrative expenses, and the $2.0 million cost associated with the reacquisition of the MicroPine license from Bausch + Lomb.

For the full year 2023, Eyenovia reported annual net income of -$27.3 million, annual revenue of $3,787, annual operating cash flow of -$23.8 million, and annual free cash flow of -$27.8 million. The company's financial performance in 2023 reflects the continued investment in the development and commercialization of its product portfolio.

MicroPine: Addressing the Epidemic of Pediatric Progressive Myopia

Eyenovia's lead product candidate, MicroPine, is an investigational 8 microliter ophthalmic spray of atropine delivered by the Optejet device, currently being evaluated as a potential treatment for pediatric progressive myopia. Pediatric progressive myopia has been called an epidemic in the United States and China, where approximately 5 million children are at higher risk of losing functional vision due to this disease.

The company is continuing to advance the Phase III CHAPERONE study for MicroPine and is exploring a potential protocol amendment that could greatly expedite the study timelines and registration of the product. This protocol amendment would include a planned limited review of the CHAPERONE data by an independent data safety monitoring committee later in the fourth quarter of 2024, when approximately two-thirds of CHAPERONE patients will have reached the study efficacy endpoint. If recommended by the committee, Eyenovia could potentially be looking at a substantially de-risked program, enabling a potential NDA submission as soon as late 2025 or early 2026.

Clobetasol Propionate Ophthalmic Suspension 0.05%: A Differentiated Steroid for Post-Surgical Inflammation and Pain

In August 2023, Eyenovia acquired the exclusive U.S. rights to commercialize clobetasol propionate ophthalmic suspension 0.05%, which was approved by the FDA on March 4, 2024. Clobetasol is the first new ophthalmic steroid to be approved in the U.S. in over 15 years and addresses many of the unmet needs for an ophthalmic steroid with a highly differentiated clinical and pharmacologic profile.

Clobetasol's efficacy and safety profile is a key point of differentiation, with nearly nine out of 10 patients achieving complete absence of post-surgical pain and six out of 10 achieving total absence of inflammation within 15 days post-ocular surgery. Additionally, clobetasol has a twice-a-day dosing regimen, which is more convenient for patients compared to other ophthalmic steroids that require dosing up to four times per day.

Eyenovia is preparing for a robust commercial launch of clobetasol later in the summer of 2024. The company estimates that there are more than 7 million ocular surgeries in the U.S. each year, with topical ocular steroids and steroid combinations currently totaling $1.3 billion in sales. Eyenovia believes it can capture a mid-single-digit market share of this opportunity over the next three to four years.

MydCombi: Commercializing the First FDA-Approved Fixed Combination Mydriatic Spray

MydCombi, Eyenovia's first FDA-approved product, is the only fixed combination of the two leading mydriatic agents, tropicamide and phenylephrine, in the United States. The company is in the process of building out its 12-person sales force and has satisfied state licensing requirements in states covering over two-thirds of the U.S. population for the distribution of MydCombi.

The sales process for MydCombi involves demonstrating and training the office staff on the use of the Optejet device, which delivers the mydriatic spray. To date, the sales team has trained and converted about 50 offices, many of whom are sharing their positive experiences with the product on social media.

Eyenovia believes MydCombi offers several benefits over traditional mydriasis eye drops, including improved cost-effectiveness, more efficient use of office time and resources, and an overall improved doctor-patient experience. The company recently completed a Phase IV study that demonstrated the potential for a lower dose of MydCombi to achieve clinically relevant pupil dilation, which could be beneficial for certain eye care patients.

Licensing and Collaboration Agreements: Expanding Reach and Unlocking Value

Eyenovia has several licensing and collaboration agreements that are contributing to the company's growth and providing non-dilutive funding. The company's licensing agreement with Arctic Vision covers the development and commercialization of MicroPine, MicroLine, and MydCombi in Greater China and South Korea. To date, this agreement has generated approximately $16 million in license fees, and Eyenovia has the potential to earn an additional $25 million in non-dilutive net license and development milestones from Arctic Vision over the next three to four years.

In addition, Eyenovia recently entered into a co-promotion agreement with NovaBay Pharmaceuticals, whereby NovaBay will market Eyenovia's clobetasol product through its U.S. physician-dispensed channel. This agreement also gives Eyenovia access to NovaBay's prescription Avenova Antimicrobial Lid & Lash Solution, which the company's sales force will promote to eye care professionals.

Eyenovia is also exploring potential pipeline expansion opportunities, including a collaboration with SGN Nanopharma to develop a formulation of SGN's Phase III-ready ophthalmic cyclosporin for use with the Optejet device as a potential treatment for chronic dry eye disease.

Financial Position and Outlook

As of March 31, 2024, Eyenovia had unrestricted cash of approximately $8 million, which does not include the $2.2 million of additional capital the company raised in April 2024. The company has reduced its planned spending by approximately $800,000 per quarter compared to the first quarter of 2024 cash-based operating expense levels and is focusing its resources on validating the Gen 2 Optejet device with the FDA, commercializing MydCombi and clobetasol, and completing the MicroPine CHAPERONE study.

Eyenovia is exploring several options and structures to ensure it has sufficient capital to support these programs and continue to execute on its growth strategy. The company believes the steps it has taken to date, including the reacquisition of the MicroPine license, the co-promotion agreement with NovaBay, and the potential for significant development and regulatory milestones from its licensing agreement with Arctic Vision, will drive meaningful sales growth in 2025 and beyond.

Risks and Challenges

While Eyenovia has made significant progress in advancing its product portfolio and commercial initiatives, the company faces several risks and challenges, including:

1. Successful commercialization of its approved products, MydCombi and clobetasol, and the ability to capture market share in competitive markets. 2. Timely and successful development and regulatory approval of its late-stage asset, MicroPine, for the treatment of pediatric progressive myopia. 3. Ability to secure additional capital to fund its operations and growth initiatives, particularly in the current challenging capital market environment for small-cap life sciences companies. 4. Potential manufacturing and supply chain disruptions that could impact the company's ability to meet customer demand. 5. Competition from other ophthalmic products and technologies that may offer similar or superior efficacy, safety, and convenience.

Conclusion

Eyenovia is well-positioned for accelerated growth in 2025 and beyond, with a diversified portfolio of FDA-approved products, a late-stage asset in MicroPine, and a robust pipeline of opportunities leveraging its proprietary Optejet delivery platform. The company's focus on commercializing its approved products, advancing the development of MicroPine, and exploring strategic partnerships and collaborations to expand its reach and unlock value, positions Eyenovia as a compelling investment opportunity in the ophthalmic pharmaceutical space.