Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Investor Presentation (June 2022)
22 slides from Aquestive Therapeutics's investor presentation, Jun 16, 2022
Slide 1: Aquestive Therapeutics Corporate Presentation
Advancing medicines. Solving problems. Improving lives. Advancing medicines. Solving problems. Improving lives. June 2022 Aquestive Therapeutics Corporate Presentation
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: Our Path
Advancing medicines. Solving problems. Improving lives. Our Path Proven track record of success • Technology-based pharmaceutical company • 5 FDA-approved products • 10+ years of product sales • 200+ patents worldwide 3 • Near-term pipeline catalysts • AQST-109 Epinephrine Oral Film ‒ First and only
Slide 4: PharmFilm Technology – Where You Need It, When You Need It
Advancing medicines. Solving problems. Improving lives. PharmFilm® Technology – Where You Need It, When You Need It™ 4
Slide 5: Our Team
Advancing medicines. Solving problems. Improving lives. Our Team Daniel Barber President, CEO and Director Peter Boyd SVP, Business Process & Information Technology Lori J. Braender General Counsel and Chief Compliance Officer Ken Marshall Chief Commercial Officer Mark Schobel Chief Innovation & Tec
Slide 6: Our Products
Advancing medicines. Solving problems. Improving lives. Our Products AQST-108-SF (Epinephrine) (Alternative Indications) AQST-109-SF (Epinephrine) (Anaphylaxis) Proprietary growth drivers Preclinical Clinical Filed Marketed FDA Approved 2010 Suboxone® Sublingual Film (Buprenorphine/Naloxone) (Opioid
Slide 7: AQST-109: Reimagining How to Treat Anaphylaxis
Advancing medicines. Solving problems. Improving lives. AQST-109: Reimagining How to Treat Anaphylaxis 7
Slide 8: Anaphylaxis: A Serious Systemic Hypersensitivity Reaction
Advancing medicines. Solving problems. Improving lives. Anaphylaxis: A Serious Systemic Hypersensitivity Reaction That is Usually Rapid in Onset And May Be Fatal1 As many as 49 million people in the United States are at chronic risk for acute anaphylactic episodes2 Lifetime prevalence may be higher
Slide 9: Epinephrine Auto-injectors, The Current Standard of Care, Are Challenging
Advancing medicines. Solving problems. Improving lives. Epinephrine Auto-injectors, The Current Standard of Care, Are Challenging Patients and caregivers using epinephrine auto-injectors often experience fear, anxiety, and needle phobia1,2 – Needle fear has been reported in 68% of children aged 6 to
Slide 10: AQST-109: Potential to Solve These Issues
Advancing medicines. Solving problems. Improving lives. AQST-109: Potential to Solve These Issues 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: 1
Slide 11: AQST-109: Pharmacokinetic Values Comparable to Existing Auto-injectors in EPIPHAST Part 2
Advancing medicines. Solving problems. Improving lives. AQST-109: Pharmacokinetic Values Comparable to Existing Epinephrine Auto-injectors in Part 2 of EPIPHAST Trial 11 • Favorable time to maximum concentration (Tmax) • Partial area under the curve (AUC) out to 30 minutes Description† AQST-109 12 m
Slide 12: AQST-109: Pharmacodynamic Values Compared Favorably to Auto-injectors
Advancing medicines. Solving problems. Improving lives. AQST-109: Pharmacodynamic (PD) Values Compared Favorably to Epinephrine Auto-injectors in Part 2 of EPIPHAST 12 “ “ • Administration of epinephrine is known to cause an increase in systolic blood pressure over time • Quantifying the increase in
Slide 13: AQST-109: Rapid Absorption With Favorable PK From Part 3 of EPIPHAST
Advancing medicines. Solving problems. Improving lives. AQST-109: Rapid Absorption With Favorable PK Per Initial Data From Part 3 of EPIPHAST Trial 13 • Tmax of 12 minutes at target 4-minute hold time*, compared to 50 minutes for 0.3mg IM • AUC within clinically relevant periods of 10, 20 & 30 minut
Slide 14: AQST-109: Development Steps
Advancing medicines. Solving problems. Improving lives. 14 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
Slide 15: Solving Problems in Epilepsy
Advancing medicines. Solving problems. Improving lives. Solving Problems in EPILEPSY 15
Slide 16: Solving Problems in Epilepsy: Sympazan and Libervant
Advancing medicines. Solving problems. Improving lives. • Commercialized for Lennox-Gastaut syndrome (LGS), a rare, severe form of epilepsy characterized by multiple manifestations of cognitive impairment and developmental delays1 Solving Problems in EPILEPSY: 16 ≈700K prescriptions annually3 have s
Slide 17: Continued Expansion of Epilepsy Franchise
Advancing medicines. Solving problems. Improving lives. Continued Expansion of Epilepsy Franchise SYMPAZAN: Sustained Script Growth for Over 13 Quarters • Growing prescriber base: over 35% penetration into the focused group of prescribers, with ~80% writing multiple scripts • Launched as a precursor
Slide 18: Libervant: NDA Resubmission, Ready to Launch
Advancing medicines. Solving problems. Improving lives. LIBERVANT: NDA Resubmission Ready to LAUNCH • if granted U.S. market access 18 PDUFA Date • December 23, 2021 Ongoing interactions with the FDA "...[FDA] is actively working on the orphan-drug exclusivity issues related to your NDA. OOPD is als
Slide 19: Financial Summary
Advancing medicines. Solving problems. Improving lives. Financial Summary (NASDAQ: AQST) 19 Capital • $8M registered direct offering closed June 8 • Available shelf registration, ATM and Common Stock Purchase Agreement Full Year 2022 Guidance (as of May 3, 2022) • Total revenues of approximately $42
Slide 20: 2022 Inflexion Points
Advancing medicines. Solving problems. Improving lives. 2022 Inflexion Points • Launch of LIBERVANT if granted U.S. market access • Continue to grow SYMPAZAN prescriptions • AQST-109 • Q2/Q3: EPIPHAST study completion • Q3: Repeat dosing comparative study AQST-109 & 0.3 mg EpiPen • H2: Request End-o
Slide 21: References
Advancing medicines. Solving problems. Improving lives. 21 References CORPORATE INFORMATION , PHARMFILM® TECHNOLOGY, SYMPAZAN®, LIBERVANT™ AND EPINEPHRINE DATA 1. van Rijckevorsel. Treatment of Lennox-Gastaut syndrome: overview and recent findings Neuropsychiatr Dis Treat. 2008;4(6):1001-1019 2. Kwa
Slide 22: Thank You
Advancing medicines. Solving problems. Improving lives. Thank You
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