Eyenovia(US:EYEN)2023-11-14 02:34Financial Data and Key Metrics Changes - For Q3 2023, the net loss was approximately $7.3 million or $0.18 per share, compared to a net loss of approximately $7.3 million or $0.21 per share for Q3 2022 [37] - Research and development expenses totaled approximately $3.6 million for Q3 2023, down from $3.9 million in Q3 2022 [18] - General and administrative expenses were approximately $2.9 million for Q3 2023, compared to $3.4 million for Q3 2022 [18] - Total operating expenses for Q3 2023 were approximately $6.5 million, down from $7.2 million in Q3 2022 [18] - Cash and cash equivalents as of September 30, 2023, were approximately $20.7 million, down from $22.9 million as of December 31, 2022 [62] Business Line Data and Key Metrics Changes - The company is preparing for the launch of Mydcombi, the first FDA-approved fixed combination of two pupil dilation drugs [7] - APP13007 is under FDA review for post-ocular surgery inflammation and pain, with potential for additional indications in the Optejet, including dry eye [11][12] - MicroPine is a significant opportunity in China for pediatric myopia, with potential for long-term funding [19] Market Data and Key Metrics Changes - The current U.S. market for pupil dilation is valued at approximately $250 million, with expectations to capture a significant market share [10] - There are approximately 7 million ocular surgeries annually, which utilize topical steroids during recovery, representing a significant market opportunity for APP13007 [31] Company Strategy and Development Direction - The company aims to leverage and monetize the Optejet technology beyond its own development programs, exploring partnerships in glaucoma and dry eye [25][32] - The FDA approved Coastline International as a contract manufacturer for Mydcombi, with production already underway [26] - The company is targeting a commercial launch of Mydcombi in early 2024 and anticipates revenue generation from this product [29][30] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming launch of Mydcombi and the potential approval of APP13007, which could significantly impact revenue [30] - The company is optimistic about the market for topical presbyopia treatments evolving and maturing [34] - Management highlighted the importance of addressing unmet needs in the ophthalmic market, particularly for patients who struggle with traditional eye drops [33] Other Important Information - The company appointed Mr. Michael Geltzeiler as an Independent Director and Chair of the Audit Committee [15] - Licensing agreements with Bausch + Lomb and Arctic Vision are progressing well, with potential for significant development and regulatory milestones [66] Q&A Session Summary Question: What are the gating factors for getting APP13007 into the clinic for dry eye disease? - The company is waiting for the PDUFA before moving forward, which will allow referencing the approved drug's preclinical and safety information [68][69] Question: Can you provide details on the drivers for Mydcombi revenue as the launch approaches? - The state licenses are falling into place, and manufacturing is underway, with expectations for first sales by the end of January [72] Question: What is the market size for dry eye treatments and how does APP13007 fit into it? - The dry eye market is significant, with APP13007 expected to provide relief for patients who are not adequately served by existing treatments [81][82]