Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Investor Presentation (November 2022)
24 slides from Aquestive Therapeutics's investor presentation, Nov 2, 2022
Slide 1: Aquestive Therapeutics Corporate Presentation
Advancing medicines. Solving problems. Improving lives. Advancing medicines. Solving problems. Improving lives. November 2022 Aquestive Therapeutics Corporate Presentation
Slide 2: Forward-Looking Statement
Advancing medicines. Solving problems. Improving lives. ® Forward-Looking Statement 2 © 2022 Property of Aquestive Therapeutics, Inc. This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate
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
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: Product Portfolio
Advancing medicines. Solving problems. Improving lives. Product Portfolio AQST-108-Sublingual Film (Epinephrine) (Alternative Indications) AQST-109-Sublingual Film (Epinephrine) (Anaphylaxis) Proprietary growth drivers Preclinical Clinical Filed Marketed FDA Approved 2010 Suboxone® Sublingual Film (
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 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: AQST-109: Significant & Addressable Market Opportunity
Advancing medicines. Solving problems. Improving lives. AQST-109: Significant & Addressable Market Opportunity 11 Total Epinephrine Auto-Injector Market Rx’s: 2015-2021 (US) Allergists, Pediatricians, and Otolaryngologists (OTOs) prescribe roughly 1/2 of all EAI Rx’s • Large portion of annual Rx’s a
Slide 12: EPIPHAST II: Topline Results
Advancing medicines. Solving problems. Improving lives. Treatment B a s e lin e A d ju s te d E p i C m a x 1 5 ( p g /m L ) 0 250 500 750 1000 1250 1500 1750 2000 IM 0.3 mg single (R1) EpiPen 0.3 mg single (R3) AQST-109 12 mg single (T1) EPIPHAST II: Topline Results Represents data from top-line re
Slide 13: EPIPHAST II: Time to Maximum Concentration (Tmax)
Advancing medicines. Solving problems. Improving lives. Baseline Adjusted Epinephrine Tmax EPIPHAST II Treatment B as el in e A d ju st ed E p i Tm ax ( m in u te s) 0 15 30 45 60 75 90 IM 0.3 mg single (R1) EpiPen 0.3 mg single (R3) AQST-109 12 mg single (T1) EPIPHAST II: Time to Maximum Concentrat
Slide 14: EPIPHAST II: Trial Summary
Advancing medicines. Solving problems. Improving lives. EPIPHAST II: Trial Summary AQST-109 compared to EpiPen 0.3mg (single dose) ❖ Confirmation of 12-minute median Tmax ❖ Faster observed median Tmax than either EpiPen (22 minutes) or 0.3mg IM injection (45 minutes) ❖ Safety profile in line with pr
Slide 15: AQST-109: Development Steps
Advancing medicines. Solving problems. Improving lives. 15 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 16: Solving Problems in Epilepsy
Advancing medicines. Solving problems. Improving lives. Solving Problems in EPILEPSY 16
Slide 17: Libervant Path to Launch
Advancing medicines. Solving problems. Improving lives. Libervant Path to Launch Libervant LAUNCH • Currently anticipating January 2027 17 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 18: Seizure Cluster Acute Rescue Market
Advancing medicines. Solving problems. Improving lives. 18 Seizure Cluster Acute Rescue Market References: 1. Symphony Health, Metys®, Jan 2021–Dec 2021. A significant unmet need exists for additional delivery options, which represents a majority of the diazepam rescue market.1 - 20,000 40,000 60,00
Slide 19: Manufacturing Operations
Advancing medicines. Solving problems. Improving lives. Manufacturing Operations 19
Slide 20: Manufacturing Operations
Advancing medicines. Solving problems. Improving lives. 20 Manufacturing Operations Manufacturing operations continues to meet the Company’s expectations and provides positive cash flow to the Company. - 10,000,000 20,000,000 30,000,000 40,000,000 50,000,000 60,000,000 PharmFilm® Volume Q3 2020 Q4 2
Slide 21: 2022 Outlook
Advancing medicines. Solving problems. Improving lives. 2022 Outlook 21
Slide 22: Financial Summary: Full Year 2022 Guidance
Advancing medicines. Solving problems. Improving lives. Financial Summary (NASDAQ: AQST) 22 Full Year 2022 Guidance (as of August 2, 2022) • Total revenues of approximately $46 to $49 million • Non-GAAP adjusted EBITDA loss of approximately $37 to $43 million
Slide 23: 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 23 Advance our novel epinephrine delivery platform AQST-109 • Q2: Completed EPIPHAST
Slide 24: Thank You
Advancing medicines. Solving problems. Improving lives. Thank You
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