Eyenovia(US:EYEN)2024-11-12 22:16Financial Performance - Eyenovia reported net losses of $7.9 million and $7.3 million for the three months ended September 30, 2024 and 2023, respectively[87]. - The company has an accumulated deficit of approximately $175.4 million as of September 30, 2024[87]. - Revenue for the three months ended September 30, 2024, totaled $1,625, primarily from Mydcombi sales, with a gross loss due to inventory write-downs of approximately $0.1 million[95]. - Revenue for the nine months ended September 30, 2024, totaled $29,243, offset by cost of revenues of $825,910, with inventory write-downs of approximately $0.8 million[100]. - The company reported net losses of $29.9 million for the nine months ended September 30, 2024, compared to $19.3 million for the same period in 2023[110]. - Net cash used in operating activities for the nine months ended September 30, 2024 was approximately $24.0 million, compared to $17.5 million for the same period in 2023, reflecting an increase of 37.1%[112]. - Net cash provided by financing activities for the nine months ended September 30, 2024 totaled approximately $16.5 million, a decrease of 14.1% from $19.2 million in 2023[114]. Expenses - Research and development expenses for the three months ended September 30, 2024, were $3.5 million, a decrease of 3% compared to $3.6 million for the same period in 2023[97]. - Selling, general and administrative expenses for the three months ended September 30, 2024, totaled $3.7 million, an increase of 27% compared to $2.9 million for the same period in 2023[98]. - Research and development expenses for the nine months ended September 30, 2024, were $12.5 million, an increase of 40% compared to $8.9 million for the same period in 2023[102]. - Selling, general and administrative expenses for the nine months ended September 30, 2024, totaled $11.1 million, an increase of 23% compared to $9.0 million for the same period in 2023[104]. - Total other expense for the three months ended September 30, 2024, was approximately $0.6 million, a decrease of 25% compared to $0.8 million for the same period in 2023[99]. - Reacquisition of license rights for the nine months ended September 30, 2024, totaled $4.9 million, compared to no expense for the same period in 2023[105]. Cash and Working Capital - Eyenovia's working capital deficit was approximately $4.1 million as of September 30, 2024[87]. - As of September 30, 2024, the company had cash and cash equivalents of $7.2 million and a working capital deficit of $4.1 million[110]. - The company has commitments to pay $5.7 million for accounts payable and accrued expenses, $0.6 million for operating lease commitments, and $10.1 million for notes payable within the next twelve months[117]. Product Development and Sales - Eyenovia's first commercial sale of FDA-approved products occurred on August 3, 2023, with a targeted launch and the onboarding of ten sales representatives through September 30, 2024[88]. - The Optejet device demonstrated a 98% success rate in drug delivery upon the first attempt, compared to approximately 50% for traditional eye drops[73]. - Eyenovia entered into a license agreement with Formosa for exclusive U.S. rights to a novel formulation of clobetasol propionate ophthalmic suspension, with an upfront payment of $2.0 million[80]. - The FDA approved the use of Mydcombi, the only fixed combination of leading mydriatic agents in the U.S., which began commercialization in August 2023[78]. - The company is developing EYEN-520 in collaboration with Senju, targeting chronic dry eye disease, with plans for a Phase 2b study completion in 2025[82]. - Eyenovia has expanded its manufacturing capabilities with new facilities in Reno, Nevada, and Redwood City, California, approved by the FDA for production[76]. - The company is in discussions with manufacturers of existing ophthalmic medications to explore development opportunities using Optejet technology[79]. Geopolitical and Accounting Considerations - The ongoing geopolitical conflicts, including the war between Russia and Ukraine, may impact material costs, potentially affecting the company's operations and financial results[119]. - There are no off-balance sheet arrangements that could materially affect the company's financial conditions or results of operations[120]. - The company prepares its financial statements in accordance with U.S. GAAP, which requires management to make estimates that could materially impact reported financial results[121]. - The company considers certain accounting estimates critical if they involve highly uncertain assumptions that could significantly affect financial conditions or results of operations[122].