Release Date: May 15, 2024
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Positive Points
- Eyenovia Inc (EYEN, Financial) has two FDA-approved products, mid copy and clobetasol, and a third, MicroPine, in late Phase three development, addressing a market worth over $3.3 billion annually.
- The company is focusing on the successful commercialization of its products and the expedited development of MicroPine, which addresses pediatric progressive myopia, a market estimated at $1.8 billion annually in the US.
- Eyenovia Inc (EYEN) has implemented a robust commercial strategy, including hiring a dedicated sales force and entering co-promotion agreements to enhance market penetration and sales reach.
- The company's Optejet technology offers a unique delivery system for ophthalmic medications, potentially improving patient compliance and efficacy.
- Eyenovia Inc (EYEN) is actively exploring additional pipeline expansion opportunities and leveraging its Optejet technology to address unmet needs in large ophthalmic indications.
Negative Points
- Eyenovia Inc (EYEN) reported a net loss of approximately $10.9 million for the first quarter of 2024, an increase from a net loss of $5.7 million in the first quarter of 2023.
- The company's research and development expenses increased by 75.7% to approximately $4.4 million for the first quarter of 2024, reflecting higher costs associated with advancing its product pipeline.
- Eyenovia Inc (EYEN) is facing challenges in the capital markets for small-cap life sciences companies, which could impact its ability to raise necessary funds.
- The company is dependent on the successful development and commercialization of MicroPine, which is still in Phase three and not yet approved by the FDA.
- Eyenovia Inc (EYEN) is in the process of transitioning to a Gen two device for its Optejet technology, which requires FDA approval and could pose risks if not successfully implemented.
Q & A Highlights
Q: Hey, guys, thanks for taking the question and congrats on the progress during the quarter. Can you talk a little bit more about the transition that you're planning to the gen-2 device and on for your portfolio of products and what you think it will take to get the thumbs-up from FDA for that size?
A: Michael Rowe, CEO of Eyenovia Inc, explained that the transition to the Gen-2 device involves demonstrating its performance equivalence to the Gen-1 device and conducting a small bridging study. The company anticipates an FDA meeting by mid-July, followed by the manufacturing of Gen-2 supply and a bridging study. The goal is to file an SNDA by the end of the next year, with confidence in meeting all necessary requirements.
Q: On Micropine, you plan to meet with the FDA soon. When do you think you'll have that squared away in terms of the protocol amendment and be able to do that analysis in the fourth quarter?
A: CEO Michael Rowe mentioned that the protocol amendment for Micropine does not require an FDA meeting. An independent data monitoring committee will review the data around mid-October. Depending on the committee's feedback, the company will approach the FDA to discuss potential study cessation and analysis, aiming for a meeting a couple of months post-review.
Q: Thank you, Michael and team, and thanks for taking our questions. Exciting to see the new commercial opportunities here in the near term. For Optejet development in presbyopia with aperture, what would you like to see from the overall presbyopia market to have aperture be more of a top strategic priority?
A: Michael Rowe responded that the company is observing the market performance of existing products, which currently underperform expectations. They are comfortable letting others invest in market development at this stage, preferring to enter with a differentiated product once the market demonstrates significant growth.
Q: How should we think about the runway situation given the reduction in spending and other adaptations to your plan?
A: CFO John Gandolfo explained that current cash reserves, along with reimbursements and product launch margins, provide sufficient resources until the MicroPine data readout in late 2024. The company has flexibility in its spending, particularly with project-based expenses, allowing further financial adjustments if necessary.
Q: With regard to Gen two, are we still dependent upon Gen two to get a cost of goods structure that will help you achieve profitability?
A: John Gandolfo confirmed that Gen two is crucial for improving cost efficiency, projecting significantly lower costs compared to Gen one. This improvement is expected to drive profitability across the company’s product lines.
Q: How is Formosa doing with getting the export approval worked out?
A: CEO Michael Rowe indicated that the Taiwanese FDA is finalizing its inspection, with expectations to start product shipments by early to mid-July, aiming for a market launch by August 1st.
For the complete transcript of the earnings call, please refer to the full earnings call transcript.
