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Aquestive Aquestive Therapeutics Reports Second Quarter 2021 Financial Results , Provides Business Update and Raises Full Year Revenue Guidance August 3 , 2021 • Libervant ™ NDA resubmission accepted , PDUFA goal date of December 23 , 2021 • On track to report top - line data from Phase 1 study for AQST - 109 epinephrine sublingual film in second half 2021 • Increases full year revenue guidance • Hosts conference call at 8:00 a.m. ET on August 4 , 2021 WARREN , N.J. , Aug. 03 , 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 second quarter ended June 30 , 2021 and provided an update on recent developments in its business . " We continue to make progress , as committed , on the key value drivers for Aquestive . The FDA has accepted for filing the NDA for Libervant and assigned a PDUFA target goal date of December 23 , 2021. We are in active dialogue with the FDA and remain focused on bringing our non - invasive and innovative product to the underserved population of patients with refractory epilepsy . Enrollment in the Phase 1 PK study for AQST - 109 , a potential oral alternative to injectable epinephrine such as EpiPenⓇ , is progressing well and we are on track to report top - line data as promised in the second half of 2021 , " said Keith Kendall , Chief Executive Officer of Aquestive . " Moreover , Sympazan and our other on - going business activities generated solid operating results during the first half of 2021. As a result , we have raised our full year revenue expectations and continued to strengthen our capital position . And , finally , we strengthened the management team by adding in June a permanent , experienced CFO in Ernie Toth . " 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 . Aquestive is developing Libervant as an alternative to Diastat ( diazepam rectal gel ) , the current standard of care rescue therapy for patients with refractory epilepsy which , as a rectal gel , is invasive , inconvenient , and difficult to administer . As a result , 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 U.S. Food and Drug Administration ( 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 for epileptic seizures . The FDA has accepted for filing the resubmission of the New Drug Application ( NDA ) for Libervant ™ ( diazepam ) Buccal Film for the management of seizure clusters . The FDA has assigned a Prescription Drug User Fee Act ( " PDUFA " ) target goal date of December 23 , 2021. Aquestive received a Complete Response Letter ( CRL ) from the FDA in September 2020 , completed a Type A meeting with the FDA in November 2020 and received further guidance from the FDA in February 2021. Based upon the Agency's guidance , the submission included additional statistical modeling and supporting analyses of the existing clinical data . The Company continues to believe that no additional clinical studies will be required for FDA approval of Libervant for U.S. market access . Epinephrine Aquestive continues to advance its developments of two product candidates , AQST - 108 and AQST - 109 , for the treatment of severe allergic reactions , including anaphylaxis , utilizing Aquestive's PharmFilm ® technologies . Aquestive is conducting a two part Phase 1 ( pharmacokinetic ) PK trial of AQST - 109 in Canada and is on track to report top - line data from this study in the second half of 2021. The Company continues to conduct non - clinical modeling analysis of AQST - 108 in allergic reactions , including anaphylaxis . We are preparing to request a meeting with the FDA in the second half of 2021 to discuss next steps in the development of AQST - 108 . SympazanⓇ 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 approximately 14 % sequentially quarter over quarter and 57 % 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 78 % of those prescribers writing multiple prescriptions . Second Quarter 2021 Financials Total revenues were $ 15.3 million in the second quarter 2021 , compared to $ 21.7 million in the second quarter 2020. Second quarter 2020 included a one - time $ 12 million recognition of license and royalty revenue as a result of the KYNMOBIⓇ FDA approval . For the second quarter 2021 compared to the prior year period , the Company saw a 57 % increase in Sympazan net revenue and a 47 % increase in manufacture and supply revenue . Aquestive's net loss for the second quarter 2021 was $ 12.4 million , or $ 0.33 loss per share . The net loss for the second quarter 2020 was $ 2.3 million , or $ 0.07 loss per share . The year - over - year change in net loss was driven by lower revenue and an increase in non - cash interest expense related to the KYNMOBIⓇ monetization transaction , which does not represent a cash output or monetary obligation at any time during the life of the transaction . Adjusted EBITDA loss was $ 4.1 million in the second quarter 2021 , compared to a $ 2.9 million gain in the second quarter of 2020. The year - over - year change in adjusted EBITDA was driven by lower revenue as described above . As of June 30 , 2021 , cash and cash equivalents were $ 34.2 million . During the second quarter 2021 , Aquestive accessed capital under its " At - The-