Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — H.C. Wainwright Global Investment Conference 2022
26 slides from Aquestive Therapeutics's conference presentation, Sep 13, 2022
Slide 1: Aquestive Therapeutics H.C. Wainwright
Advancing medicines. Solving problems. Improving lives. Advancing medicines. Solving problems. Improving lives. September 2022 Aquestive Therapeutics H.C. Wainwright
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: Strategic Priorities
Advancing medicines. Solving problems. Improving lives. Strategic Priorities Proven track record of success • Technology-based pharmaceutical company • 5 FDA-approved products • 10+ years of product sales • 200+ patents worldwide • 23 filed patents covering AQST‐109 • 19 patents covering LibervantTM
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 © 2022 Property of Aquestive Therapeutics, Inc.
Slide 5: Experienced Team
Advancing medicines. Solving problems. Improving lives. Experienced 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 Innovati
Slide 6: Scientific Advisory Board with Allergy Expertise
Advancing medicines. Solving problems. Improving lives. Scientific Advisory Board with Allergy Expertise David Bernstein, MD Carlos Camargo, MD David M. Fleischer, MD Matthew Greenhawt, MD Ruchi Gupta, MD, MPH Jay Lieberman, MD 6 David Golden, MD John Oppenheimer, MD © 2022 Property of Aquestive The
Slide 7: Product Portfolio
Advancing medicines. Solving problems. Improving lives. Product Portfolio 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) (O
Slide 8: AQST-109: Commercial Opportunity
Advancing medicines. Solving problems. Improving lives. AQST-109: Commercial Opportunity 8
Slide 9: 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 10: AQST-109: Potential to Solve These Issues
Advancing medicines. Solving problems. Improving lives. AQST-109: Potential to Solve These Issues 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: 10 Quickly delive
Slide 11: Physician Research: Concerns About Patients Having EAI With Them
Advancing medicines. Solving problems. Improving lives. 11 How concerned are you with patients and/or their caregivers consistently having their auto-injector(s) with them when they leave home? Physician Research: Concerns About Patients Having EAI With Them at All Times 1% 4% 7% 25% 23% 24% 16% 0%
Slide 12: Patient Survey: Impact, Epinephrine On Hand
Advancing medicines. Solving problems. Improving lives. 12 Patient Survey: Impact, Epinephrine On Hand 6% 94% 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% False True I believe the smaller package would make it more likely for me to have the film with me when I need it (vs EAI): *Aquestive sponsored o
Slide 13: AQST-109: Commercial Opportunity
Advancing medicines. Solving problems. Improving lives. 13 PharmFilm® delivers market share within existing market Aquestive allergy franchise delivers market expansion AQST-109: Commercial Opportunity Features/benefits customers are looking for in a new epinephrine delivery: • Portability • Usabili
Slide 14: AQST-109: Potential Annual Peak Net Sales
Advancing medicines. Solving problems. Improving lives. 14 AQST-109: Potential Annual Peak Net Sales* o No market expansion o PharmFilm share <30% $500M$250M o Modest market expansion o PharmFilm share = 30% - 50% o Significant market expansion o PharmFilm share >50% *Potential revenues are internal
Slide 15: AQST-109: Development Pathway
Advancing medicines. Solving problems. Improving lives. AQST-109: Development Pathway 15
Slide 16: AQST-109: Critical Therapeutic Parameters
Advancing medicines. Solving problems. Improving lives. AQST-109: Critical Therapeutic Parameters 16 “ “ • Is there sufficient drug absorption to bridge to efficacy? • Maximum drug plasma concentrations (Cmax) • Systolic / diastolic blood pressure – change from baseline • Heart rate – change from ba
Slide 17: AQST-109: Part of EPIPHAST Trial Demonstrates Rapid Absorption
Advancing medicines. Solving problems. Improving lives. AQST-109: Part 3 of EPIPHAST Trial Demonstrates Rapid Absorption 17 • Tmax of 12 minutes vs. 50 minutes for IM • Higher AUC within clinically relevant periods of 10, 20 & 30 minutes compared to IM • Median time to reach 100 pg/mL (suggested as
Slide 18: 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 EPIPHAST Trial 18 “ “ • Administration of epinephrine is known to cause an increase in systolic blood pressure over time • Quantifying the increase in sys
Slide 19: AQST-109: Rapid Absorption With Comparable PK Under Various Conditions
Advancing medicines. Solving problems. Improving lives. AQST-109: Rapid Absorption With Comparable PK Under Various Administration Conditions In Part 3 of EPIPHAST Trial • Study results for the sublingual administration of AQST-109 epinephrine sublingual film after consuming a peanut butter sandwich
Slide 20: AQST-109: Development Steps
Advancing medicines. Solving problems. Improving lives. 20 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 21: Libervant (diazepam) Buccal Film Update
Advancing medicines. Solving problems. Improving lives. LibervantTM (diazepam) Buccal Film Update 21
Slide 22: Seizure Cluster Acute Rescue Market
Advancing medicines. Solving problems. Improving lives. 22 Seizure Cluster Acute Rescue Market • Availability of therapeutics candidates addressing the new routes of administration over the past three years was expected to nearly double the labeled rescue market1 • Approaching $230M in net revenue f
Slide 23: Libervant Path to Launch
Advancing medicines. Solving problems. Improving lives. Libervant Path to Launch Libervant LAUNCH • Currently anticipating January 2027 23 PDUFA Date • December 23, 2021 Tentative Approval Received • August 30, 2022 Potential Path Forward H2 2022 Engage with FDA on study design Conduct head-to-head
Slide 24: Financial Summary
Advancing medicines. Solving problems. Improving lives. Financial Summary (NASDAQ: AQST) 24 Capital • $8 million registered direct offering closed on June 8, 2022 • Available shelf registration and ATM Full Year 2022 Guidance (as of August 2, 2022) • Total revenues of approximately $46 to $49 millio
Slide 25: Going Forward
Advancing medicines. Solving problems. Improving lives. Going Forward Continued leverage of expertise and technology • 5 FDA-approved products • Tentative approval of LIBERVANT granted and anticipated launch in 2027 25 Advance our novel epinephrine delivery platform AQST-109 • Q2: Completed EPIPHAST
Slide 26: Thank You
Advancing medicines. Solving problems. Improving lives. Thank You
Aquestive Therapeutics — H.C. Wainwright Global Investment Conference 2022 on 6ix