Page 1

Aquestive Aquestive Therapeutics Reports First Quarter 2021 Financial Results and Provides Business Update May 4 , 2021 • On track to refile Libervant ™ ( diazepam ) Buccal Film New Drug Application ( NDA ) by end of second quarter 2021 • Initiated first - in - human Phase 1 pharmacokinetic ( PK ) study for AQST - 109 epinephrine sublingual film candidate SympazanⓇ ( clobazam ) continues to meet key performance metrics and gain market share • • Hosts conference call at 8:00 a.m. ET on May 5 , 2021 WARREN , N.J. , May 04 , 2021 ( GLOBE NEWSWIRE ) -- Aquestive Therapeutics , Inc. ( NASDAQ : AQST ) , a pharmaceutical company focused on developing and commercializing differentiated products that address patients ' unmet needs and solve therapeutic problems , today reported financial results for the first quarter ended March 31 , 2021 and provided an update on recent developments in its business . " We are focused on continuing to make progress this year in advancing our proprietary products . In response to feedback from the FDA , we are developing additional analyses of the existing clinical data in the NDA for Libervant and expect to refile by the end of the second quarter of 2021. We recently initiated the first - in - human Phase 1 PK study with our second generation epinephrine candidate AQST - 109 and anticipate reporting top - line data in the second half of the year , " said Keith Kendall , President and Chief Executive Officer of Aquestive . Libervant ™ Libervant is a buccally , or inside of the cheek , administered soluble film formulation of diazepam , a benzodiazepine intended for rapid treatment of acute uncontrolled seizures in selected , refractory patients with epilepsy on stable regimens of AEDs who require intermittent use of diazepam to control bouts of increased seizure activity . The Company is developing Libervant as an alternative to more invasive , inconvenient , and difficult to administer device driven products , including a rectal gel , for patients with refractory epilepsy . As a result of these issues , a large portion of the patient population does not receive adequate treatment or foregoes treatment altogether . The Company believes that Libervant , if approved by the FDA for U.S. market access , will enable a larger share of these patients to receive more appropriate treatment by providing consistent therapeutic dosing in a non - invasive and innovative treatment form . The Company previously received a Complete Response Letter ( CRL ) from the FDA in September 2020. Since September , Aquestive has engaged with the FDA and developed a plan to address the deficiencies noted in the CRL . Aquestive continues to believe that no additional clinical studies will be required to resubmit the NDA . The Company anticipates a six month review process and PDUFA action date by the end of 2021 . Epinephrine Ⓡ Aquestive continues to advance its two product candidates , AQST - 108 and AQST - 109 , for the potential treatment of severe allergic reactions , including anaphylaxis , utilizing Aquestive's PharmFilm ® technologies . In late March 2021 , Aquestive began a two part Phase 1 PK trial of AQST - 109 in Canada and continues to conduct non - clinical modeling analysis of AQST - 108 in anticipation of engaging regulators in the second half of 2021 after the readout from both of these activities . SympazanⓇ Despite the continued limitations on provider in - person interactions caused by the COVID - 19 pandemic , the Company's proprietary product SympazanⓇ ( clobazam ) , an oral film for the treatment of seizures associated with Lennox - Gastaut syndrome , continues to meet key performance metrics . Shipment volume has grown 13 % sequentially quarter over quarter and 40 % year over year . Sympazan saw continued growth in the prescriber base , with over 30 % penetration into the Company's focused group of prescribers , with approximately 80 % of those prescribers writing multiple prescriptions . First Quarter 2021 Financials Total revenues were $ 11.1 million in the first quarter 2021 , compared to $ 8.8 million in the first quarter 2020. This year - over - year increase reflected higher license and royalty revenue and growth in Sympazan revenue . Aquestive saw net revenue growth in the first quarter 2021 , compared to the prior year period , of 56 % for Sympazan , the first of its proprietary products to be launched . Aquestive's net loss for the first quarter 2021 was $ 14.7 million , or $ 0.41 loss per share . The net loss for the first quarter 2020 was $ 16.5 million , or $ 0.49 loss per share . The year - over - year change in net loss was driven by higher revenue and reductions in costs and expenses , partly offset by increased interest expense related to the sale of future revenue . This increase in interest expense was due to the accounting associated with the KYNMOBIⓇ monetization transaction which closed on November 3 , 2020 and does not represent a cash output or monetary obligation at any time during the life of the transaction . Adjusted EBITDA loss was $ 6.3 million in the first quarter 2021 , compared to $ 11.2 million in the first quarter of 2020 . The year - over - year change in adjusted EBITDA loss was driven by higher revenue and reductions in costs and expenses . As of March 31 , 2021 , cash and cash equivalents were $ 27.5 million . During the first quarter 2021 , Aquestive accessed capital under its " At - The- Market " ( ATM ) facility resulting in net proceeds of $ 9.9 million . 2021 Outlook Aquestive is maintaining its full year 2021 financial outlook . The Company expects :