Eyenovia(US:EYEN)2023-08-13 13:24Financial Data and Key Metrics Changes - For Q2 2023, the net loss was approximately $6.2 million or $0.16 per share, compared to a net loss of approximately $7.2 million or $0.22 per share for Q2 2022, indicating an improvement in financial performance [19] - Research and development expenses totaled approximately $2.8 million for Q2 2023, down from $3.6 million in Q2 2022 [19] - General and administrative expenses were approximately $3.1 million for Q2 2023, compared to $3.5 million for Q2 2022 [19] - Total operating expenses for Q2 2023 were approximately $6 million, a decrease from $7.1 million in Q2 2022 [20] - As of June 30, 2023, cash and cash equivalents were approximately $17.5 million, down from $22.9 million as of December 31, 2022 [20] Business Line Data and Key Metrics Changes - The company initiated sales of Mydcombi, the first FDA-approved product leveraging the Optejet dispensing device, to a targeted group of professional offices [8][9] - The first commercial sale of Mydcombi was made to Dr. Nathan Radcliffe, marking a significant milestone in the product's launch [9] - The company is in the process of adding additional commercial manufacturing sites to support Mydcombi, including the Redwood City facility and Coastline manufacturing [10] Market Data and Key Metrics Changes - The addressable market for Apersure, a therapeutic candidate for presbyopia, represents over 18 million people in the U.S. aged 40 to 55, with a potential annual market of nearly $1 billion [12] - The company is actively discussing partnerships with no fewer than four companies across various topical ophthalmic markets to leverage the Optejet technology [11] Company Strategy and Development Direction - The company aims to leverage and monetize the Optejet technology through partnerships, focusing on marrying delivery technology with unique drug assets [11] - The company is targeting the initiation of Apersure registration batches in Q4 2023, with plans to file a new drug application approximately 12 months after running registration batches [13] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the progress made in Q2 2023, highlighting the FDA approval of Mydcombi and the initiation of sales [26] - The company anticipates better visibility for Mydcombi's guidance with the upcoming Coastline manufacturing approval [39] - Positive feedback from early users of Mydcombi indicates a favorable reception, with reports of shorter dilation duration compared to traditional eye drops [40] Other Important Information - Eyenovia was added to the small-cap Russell 2000 and broad market Russell 3000 indices effective June 2023 [25] - The company has generated approximately $16 million in license fees from existing agreements, with potential to earn an additional $60 million in net license and development milestones over the next four years [24] Q&A Session Summary Question: Future of Gen 2 Device Development - Management confirmed that all devices will eventually transition to the Gen 2 design, which is simpler and less costly to manufacture [30] Question: Status of Presbyopia Studies - Some studies related to the Gen 2 device are completed, while others are ongoing, with all expected to be finished by the end of the year [31] Question: Launch Progress of Mydcombi - Management indicated that the initial launch is targeted, with better visibility expected after the Coastline manufacturing approval [39] - Early feedback from users of Mydcombi has been positive, with reports of effective and shorter dilation duration [40]