Aquestive(US:AQST)2025-05-12 20:37Financial Position - The company reported a strong balance sheet with approximately $68.7 million in cash as of March 31, 2025 [10] - The company projects a cash runway into 2026 [10, 19] - The company expects total revenues of approximately $44-$50 million for 2025 [26] - The company anticipates a Non-GAAP adjusted EBITDA loss of approximately $47-$51 million for 2025 [26] Product Development & Regulatory Milestones - The NDA for Anaphylm (epinephrine) Sublingual Film was submitted in Q1 2025 [11] - The FDA acceptance of the NDA for Anaphylm is expected in Q2 2025 [11, 18] - The pediatric clinical trial for Anaphylm has been completed with positive top-line results [11] - The company is preparing for a potential Anaphylm launch in Q1 2026, pending FDA approval [11] Market & Manufacturing - Manufacturing operations continue to generate cash flow [21] - The company shipped 27,392 doses in Q1 2025 [22] - Market research indicates that 80% of patients and HCPs prefer a non-injection dosing method for epinephrine [14] - Market research indicates that 95% of patients and HCPs are interested in a film-dosing option [14] - Market research indicates that 85% of healthcare providers indicated they would prescribe a film-dosing option [16]