Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Investor Presentation (March 2023)
26 slides from Aquestive Therapeutics's investor presentation, Mar 7, 2023
Slide 1: Corporate Presentation March 2023
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL Advancing medicines. Solving problems. Improving lives. Corporate Presentation March 2023 1
Slide 2: Disclaimer
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL ® Disclaimer This presentation contains “forward-looking” statements that are based on the beliefs and assumptions and on information currently available to management of Aquestive Therapeutics, Inc. (together with its consolidated
Slide 3: Our Quest
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL Our Quest ●Advancing medicines to solve therapeutic problems ●Delivering clinical and therapeutic advances ● Improving patients lives 3
Slide 4: Our Strategic Priorities
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL Our Strategic Priorities 4 Proven track record of success • Technology-based pharmaceutical company • 5 FDA-approved products • 10+ years of product sales on 6 continents • 200+ patents worldwide 23 filed patents covering AQST- 1
Slide 5: PharmFilm Technology – Where You Need It, When You Need It
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL PharmFilm® Technology – Where You Need It, When You Need It™ 5
Slide 6: Product Portfolio – Significant Partnering Opportunities in 2023
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL Product Portfolio – Significant Partnering Opportunities in 2023 AQST-108 formulation (epinephrine) (Alternative Indications) AQST-109 (epinephrine) Sublingual Film (Anaphylaxis) Proprietary growth drivers Preclinical Clinical File
Slide 7: Product Licenses on Continents
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL Product Licenses on 6 Continents 7
Slide 8: Potential for Two Transformative Launches
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL Potential for Two Transformative Launches 8 AQST-109 (epinephrine) Sublingual Film • Potential indication of treatment of severe allergic reactions including, anaphylaxis • Anticipate filing NDA in mid-2024 • Addressable Market of
Slide 9: Strong Leadership Team
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL Strong Leadership Team Daniel Barber President, CEO and Director Lori J. Braender SVP, General Counsel Ken Marshall Chief Commercial Officer Mark Schobel Chief Innovation & Technology Officer Ernie Toth Chief Financial Officer 9 Ca
Slide 10: Anaphylaxis Market Overview
Advancing medicines. Solving problems. Improving lives. Anaphylaxis Market Overview 10
Slide 11: Anaphylaxis: A Serious Systemic Hypersensitivity Reaction
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL Anaphylaxis: A Serious Systemic Hypersensitivity Reaction That is Usually Rapid in Onset And May Be Fatal1 11 1. Turner PJ, et al. World Allergy Org J. 2019;12100066 2. FARE, 2022; https://www.foodallergy.org/resources/facts-and-st
Slide 12: Treatment of Anaphylaxis – Epinephrine
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL Treatment of Anaphylaxis – Epinephrine • Epinephrine is the first line of treatment for anaphylaxis • Epinephrine is the only medication proven to stop a life-threatening allergic reaction • Epinephrine dosage (current medication d
Slide 13: Generic Market with High Levels of Dissatisfaction & Unmet Need
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL Generic Market with High Levels of Dissatisfaction & Unmet Need 13 Current Patient Choice = Large, Needle Based Injectors Numerous Studies and Patient Surveys Articulate Significant Dissatisfaction with Current Offerings • Right pl
Slide 14: Significant & Addressable Market Opportunity
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL Significant & Addressable Market Opportunity 14 Epinephrine Auto-Injector Market: 2015-20211 Allergists, Pediatricians, and Otolaryngologists (OTO) prescribe roughly 1/2 of all EAI Rx’s2 • Large portion of annual Rx’s are written b
Slide 15: Potential Analog: Seizure Cluster Acute Rescue Market
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL Potential Analog: Seizure Cluster Acute Rescue Market Availability of therapeutic candidates addressing the new routes of administration over the past three years was expected to nearly double the labeled rescue market2 1. Symphony
Slide 16: AQST-109: Reimagining How to Treat Anaphylaxis
Advancing medicines. Solving problems. Improving lives. AQST-109: Reimagining How to Treat Anaphylaxis 16
Slide 17: AQST-109 (epinephrine) Sublingual Film
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL AQST-109 (epinephrine) Sublingual Film First and only orally delivered epinephrine product candidate 17 Fast absorption into the bloodstream Non-device administrationPortability + +
Slide 18: Baseline Adjusted Epinephrine Tmax EPIPHAST II
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL Baseline Adjusted Epinephrine Tmax EPIPHAST II Treatment Ba se lin e Ad ju st ed E pi T m ax (m in ut es ) 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) Strong Clinical Data Presente
Slide 19: EPIPHAST II: Pharmacodynamic (PD) Results
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL EPIPHAST II: Pharmacodynamic (PD) Results • AQST‐109 demonstrates a pharmacodynamic response for Systolic Blood Pressure (SBP) and Pulse consistent with that of EpiPen • Pronounced early peak in PD implies rapid and robust onset of
Slide 20: Solving Problems in EPILEPSY
Advancing medicines. Solving problems. Improving lives. Solving Problems in EPILEPSY 20
Slide 21: The Unmet Need in Refractory Seizures
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL 1. Laxer, Ketal, The consequences of Refractory Epilepsy and its treatment; Epilepsy & Behavior, Vol 37, Aug 2014, Pgs 59 –70; https://doi.org/10.1016/j.yebeh.2014.05.031. 2. Triangle Insights Group (2017). Synthesis of Epilepsy (A
Slide 22: Libervant (diazepam) Buccal Film Path to Launch
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL Libervant™ (diazepam) Buccal Film Path to Launch Libervant LAUNCH • Currently anticipating January 2027 22 PDUFA Date • December 23, 2021 Tentative Approval Received • August 30, 2022 Potential Path Forward H1 2023 Await FDA commen
Slide 23: 2023 Outlook
Advancing medicines. Solving problems. Improving lives. 2023 Outlook 23
Slide 24: Financial Summary – Full Year 2023 Guidance
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL Financial Summary (NASDAQ: AQST) 24 Full Year 2023 Guidance (as of March 7, 2023) • Total revenues of approximately $37 to $41 million • Non-GAAP adjusted EBITDA loss of approximately $31 to $36 million
Slide 25: Keys to Success in 2023
Advancing medicines. Solving problems. Improving lives. CONFIDENTIAL Keys to Success in 2023 Leverage Our 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 Liber
Slide 26: Thank You
Advancing medicines. Solving problems. Improving lives. Thank You
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