Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Q2 2022 Earnings Presentation
19 slides from Aquestive Therapeutics's earnings presentation, Aug 3, 2022
Slide 1: Aquestive Therapeutics Q2 2022 Earnings Supplemental Materials
Advancing medicines. Solving problems. Improving lives. Advancing medicines. Solving problems. Improving lives. August 2022 Aquestive Therapeutics Q2 2022 Earnings Supplemental Materials
Slide 2: Forward-Looking Statement
Advancing medicines. Solving problems. Improving lives. ® Forward-Looking Statement This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,”
Slide 3: Q2 2022 Earnings: Key Messages
Advancing medicines. Solving problems. Improving lives. Q2 2022 Earnings: Key Messages Epinephrine Sublingual Film ™ Completed EPIPHAST trial that demonstrated ability to provide rapid and significant epinephrine exposure under a variety of real-world conditions ™ Initiated EPIPHAST II trial, compar
Slide 4: AQST-109: Epinephrine Sublingual Film
Advancing medicines. Solving problems. Improving lives. AQST 109: Epinephrine Sublingual Film 4
Slide 5: AQST-109: Epinephrine Sublingual Film
Advancing medicines. Solving problems. Improving lives. AQST-109: Epinephrine Sublingual Film AQST-109 is the first and only orally delivered epinephrine product candidate for the treatment of allergic reactions (type 1), including anaphylaxis, that would allow patients and their providers to: 5 Qui
Slide 6: AQST-109: Rapid Absorption With Favorable PK From Part 3 of EPIPHAST Trial
Advancing medicines. Solving problems. Improving lives. AQST-109: Rapid Absorption With Favorable Pharmacokinetic (PK) Per Initial Data From Part 3 of EPIPHAST Trial • Medium time to peak concentration (Tmax) of 12 minutes at target 4-minute hold time*, compared to 50 minutes for 0.3mg Intramuscular
Slide 7: AQST-109: Rapid Absorption With Comparable PK After Consuming Peanut Butter
Advancing medicines. Solving problems. Improving lives. AQST-109: Rapid Absorption With Comparable PK After Consuming Peanut Butter From Part 3 of EPIPHAST Trial • Study results for the sublingual administration of AQST-109 epinephrine sublingual film after consuming a peanut butter sandwich demonst
Slide 8: AQST-109: De-Risking Potential Administration Errors
Advancing medicines. Solving problems. Improving lives. AQST-109: De-Risking Potential Administration Errors From Part 3 of EPIPHAST Trial Findings • Even if film is swallowed immediately with water, substantial epinephrine absorption and exposure still occurs o Comparable Cmax and overall AUC o A T
Slide 9: AQST-109: Development Steps
Advancing medicines. Solving problems. Improving lives. 9 AQST-109: Development Steps FDA confirmed that the 505(b)2 approval path is acceptable for AQST-109 Aquestive opened its Investigational New Drug (IND) after receiving FDA clearance in February 2022 Aquestive received Fast Track Designation f
Slide 10: LIBERVANT (diazepam) buccal film
Advancing medicines. Solving problems. Improving lives. LIBERVANTTM (diazepam) buccal film 10
Slide 11: LIBERVANT (diazepam) Buccal Film
Advancing medicines. Solving problems. Improving lives. LIBERVANT™ (diazepam) Buccal Film 11 • Under FDA review for management of refractory patients with epilepsy on stable regimens of AEDs who experience seizure clusters “ “≈85% of patients with refractory seizures will not interact with the histo
Slide 12: Seizure Cluster Acute Rescue Market
Advancing medicines. Solving problems. Improving lives. 12 Seizure Cluster Acute Rescue Market References: 1. Symphony Health, Metys®, Jan 2021 –Dec 2021. - 50,000 100,000 150,000 200,000 250,000 300,000 350,000 400,000 2018 2019 2020 2021 2022 YTD 2022 EST An nu al T rx b y B ra nd Year ANNUAL TRX
Slide 13: LIBERVANT: NDA Resubmission Ready to Launch
Advancing medicines. Solving problems. Improving lives. LIBERVANT: NDA Resubmission Ready to LAUNCH • if granted U.S. market access 13 PDUFA Date • December 23, 2021 Ongoing interactions with the FDA “Thank you for your message and your patience as our Office actively works through the orphan-drug e
Slide 14: Commercial Operations
Advancing medicines. Solving problems. Improving lives. Commercial Operations 14
Slide 15: Commercial Operations: Sympazan Prescriptions by Quarter
Advancing medicines. Solving problems. Improving lives. 15 Commercial Operations Sympazan Prescriptions by Quarter (2020 – 2022) - 500 1,000 1,500 2,000 2,500 3,000 2020-Q12020-Q22020-Q32020-Q42021-Q12021-Q22021-Q32021-Q42022-Q12022-Q2 TR X B Y Q U AR TE R TRx Count • Sympazan® Trxs and the number o
Slide 16: Manufacturing Operations
Advancing medicines. Solving problems. Improving lives. 16 Manufacturing Operations • PharmFilmTM manufacturing volume increased approximately 11.5% 1H2022 compared to 1H2021 • The commercial Sympazan operations and manufacturing operations of the business continue to provide positive cash flow to t
Slide 17: 2022 Outlook
Advancing medicines. Solving problems. Improving lives. 2022 Outlook 17
Slide 18: 2022 Outlook
Advancing medicines. Solving problems. Improving lives. 2022 Outlook 2022 Outlook • Total revenues of approximately $46 to $49 million • Non-GAAP adjusted gross margins of approximately 70% to 75% • Non-GAAP adjusted EBITDA loss of approximately $37 to $43 million 18
Slide 19: Thank You
Advancing medicines. Solving problems. Improving lives. Thank You
Aquestive Therapeutics — Q2 2022 Earnings Presentation on 6ix