Aquestive Therapeutics Exceeds Top End of Guidance Range for Preliminary Unaudited Full Year 2019 Total Revenues and Provides Initial Full Year 2020 Guidance

• Anticipates full year 2019 preliminary unaudited total revenues to be approximately $52 million, exceeding previously provided full year revenue guidance
  
• Anticipates fourth quarter 2019 preliminary unaudited total revenues to be approximately $16 million
  
• Expects preliminary unaudited cash and cash equivalents as of December 31, 2019 of approximately $49 million
  
• Provides initial full year 2020 anticipated financial guidance

WARREN, N.J., Jan. 10, 2020 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ: AQST), a specialty pharmaceutical company focused on developing and commercializing differentiated products that meet patients’ unmet needs and solve therapeutic problems, today reported anticipated preliminary unaudited total revenues for the fourth quarter and full year ended December 31, 2019 and provided initial full year 2020 guidance.

“In addition to exceeding the top end of our revenue guidance, we achieved significant milestones, as promised, in 2019. First, we completed our rolling submission of the New Drug Application (NDA) for our therapeutic candidate Libervant (diazepam) Buccal Film for the management of seizure clusters to the U.S. Food and Drug Administration (FDA) in November 2019.  Next, we successfully completed a number of early stage clinical trials regarding AQST-108 (epinephrine), advancing toward our February 2020 Pre-IND meeting with the FDA to clarify the clinical and regulatory path forward.  These milestones establish a path forward in 2020 to advance our pipeline and commercial opportunities,” said Keith J. Kendall, Chief Executive Officer of Aquestive. “Sympazan continued to extend its reach in the prescribing community that will ultimately be vital to the successful launch of Libervant, subject to approval by the FDA.  We entered 2020 with a strong cash position of approximately $49 million and, with the announcement by Sunovion of a May 2020 PDUFA date for APL-130277, we believe that we have a clear timetable to work toward securing substantial additional non-dilutive capital in mid-2020.  We anticipate current capital and revenues from monetization of our rights in APL-130277, subject to approval by the FDA, to fully support our commercial activities, the expected launch of Libervant, the continued development of AQST-108 and the identification, investigation and development of additional product candidates.”