Release Date: November 12, 2024

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Eyenovia Inc (NASDAQ:EYEN) is nearing a potential phase three efficacy data readout for its pediatric progressive myopia product, Micropine, which targets a multi-billion dollar market.
• The company is advancing its next-generation Optejet technology, which is expected to improve profitability.
• Eyenovia Inc (NASDAQ:EYEN) has successfully commercialized its mydriasis product, Mydcombi, and launched Clobetasol, an advanced ocular steroid.
• The company is expanding its Optejet development pipeline in dry eye treatments, with strategic partnerships partially funding these initiatives.
• Eyenovia Inc (NASDAQ:EYEN) has entered into multiple development collaborations, potentially addressing unmet needs in acute and chronic dry eye disease.

Negative Points

• Eyenovia Inc (NASDAQ:EYEN) reported a net loss of approximately $7.9 million for the third quarter of 2024, an increase from the previous year.
• The company continues to incur losses on sales of its Gen 1 device, Mydcombi, due to inventory write-downs.
• General and administrative expenses increased by 27.3% compared to the third quarter of 2023, primarily due to commercialization efforts.
• The company is still in the process of evaluating capital raising structures to fund ongoing strategies and loan payments.
• Revenue from Mydcombi was lower than expected, with only $2000 reported for the third quarter, despite being placed in over 200 offices.

Q & A Highlights

• Warning! GuruFocus has detected 4 Warning Signs with EYEN.

Q: As we look to the chaperone trial, what are the most important distinctions for setting expectations to define success? A: Michael Rowe, CEO: The independent review committee will determine if at least one of the doses in the chaperone study has reached statistical significance over placebo. We will look at efficacy, side effect profile, compliance, and systemic exposure to atropine. These factors differentiate the Opto Jet delivered product from traditional eye drops.

Q: With the chaperone trial dosing as young as six years old, what age range is progressive myopia most commonly identified in practice? A: Michael Rowe, CEO: Children are typically identified as myopic when they are around five or six years old. The goal is to capture them early, as the progression of myopia is tied to the development of the eye, which is most rapid when children are younger.

Q: What is the potential powering of the chaperone interim analysis? A: Michael Rowe, CEO: The power calculation is around 85% with a p-value of less than 0.021. The independent review committee will assess the data to determine if there is statistical significance.

Q: Can you explain the revenue dynamics for Midcombi given the increase in the number of centers using it? A: Andy Jones, CFO: Revenue for Q3 was about $2,000. We are in over 200 offices and expect reorders to increase in Q4. The initial phase involves placing samples in offices to familiarize them with the product, leading to reorders.

Q: What advantages does the Opto Jet have over traditional dispensing for pediatric populations? A: Michael Rowe, CEO: The Opto Jet offers less systemic exposure, better topical tolerability, and compliance assistance. It is easier for children to use compared to traditional eye drops, which can be difficult to administer.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.