Aquestive(US:AQST)2022-06-19 17:56Company Overview - Aquestive Therapeutics is a technology-based pharmaceutical company with 6 FDA-approved products and over 200 patents worldwide[9] - The company has a proven track record of success with 10+ years of product sales[9] - Aquestive has multiple cash-generating opportunities, including a cash flow positive manufacturing business[9] Pipeline and Product Development - AQST-109 Epinephrine Oral Film is a first and only orally delivered epinephrine product candidate with a median time to peak concentration (Tmax) of 15 minutes; a pivotal PK study is expected to start in 2H of 2022[9] - The company resubmitted NDA for Libervant™ Buccal Film (Diazepam) on June 23, 2021, and is ready to launch if granted US market access[9] - As many as 49 million people in the United States are at chronic risk for acute anaphylactic episodes[22] - AQST-109 demonstrated a favorable time to maximum concentration (Tmax) of 15 minutes and AUC 0-30 min of 56.7 hrpg/mL compared to Epinephrine IM 0.3 mg with Tmax of 50 minutes and AUC 0-30 min of 47.5 hrpg/mL[31] Financial Performance and Guidance - The company anticipates total revenues of approximately $42 to $47 million for full year 2022[54] - Non-GAAP adjusted gross margins are expected to be approximately 70% to 75% on total revenues for 2022[54] - Non-GAAP adjusted EBITDA loss is projected to be $51 to $58 million for 2022[54] - The company has potential additional capital from a debt facility of up to $30 million, if granted U S market access for Libervant ATM (up to $36M) and a Common Stock Purchase Agreement (up to $40M)[54]