Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Investor Presentation (June 2024)
34 slides from Aquestive Therapeutics's investor presentation, Jun 7, 2024
Slide 1: Corporate Presentation June 2024
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc.1 Advancing medicines. Solving problems. Improving lives. Corporate Presentation June 2024
Slide 2: Disclaimer
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Disclaimer 2 This presentation and the accompanying oral commentary have been prepared by Aquestive Therapeutics, Inc. (“Aquestive”, the “Company”, “our” or “us”) and contains forward-looking statements within
Slide 3: Who we are
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Advancing medicines. Solving problems. Improving lives. 3 A publicly traded pharmaceutical company (NASDAQ: AQST) focused on advancing medicines to bring meaningful improvement to patients' lives through innov
Slide 4: Our drug delivery technologies
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc.4 PharmFilm® Our drug delivery technologies AdrenaverseTM Prodrug Platform Adrenaverse platform contains a library of over 20 epinephrine prodrugs that demonstrate control of absorption and conversion rates acr
Slide 5: Our approved products and collaborations
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Our approved products and collaborations 5
Slide 6: Diversified pipeline
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Diversified pipeline 6 1.. Aquestive Therapeutics data on file. 2. Annual revenue includes revenue for patients 12 and up after launch in 2027 2
Slide 7: Our end-to-end capabilities
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Formulation & analytical chemistry (CMC) leaders Regulatory experts with 6 FDA approvals Clinical trial design and execution Intellectual property know-how with 150+ patents worldwide Our end-to-end ca
Slide 8: Our growth plan
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Our growth plan 8 1. Estimate is based on an orphan drug market exclusivity block until January of 2027 by an FDA approved nasal spray product.; 2. If we meet all clinical endpoints and if filed with and appro
Slide 9: Financial results
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Financial results 9 (25.0) (20.0) (15.0) (10.0) (5.0) 0.0 5.0 2019 2020 2021 2022 2023 (U SD m ill io ns ) EBITDA excluding R&D by Year - 5.0 10.0 15.0 20.0 25.0 2019 2020 2021 2022 2023 (U SD m ill io ns ) R&
Slide 10: Dedicated and experienced leadership team
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Dedicated and experienced leadership team 10 Daniel Barber President, CEO & Director Lori J. Braender General Counsel, Chief Compliance Officer Ernie Toth Chief Financial Officer Peter Boyd SVP, HR & IT Mark S
Slide 11: Key company facts
6 drug approvals $50M+ of revenue in 2023 150+ employees based in Indiana and New Jersey More than 2 billion PharmFilm doses shipped worldwide 19+ years since the company was founded Products are available on 6 continents Over $1.5 billion in potential peak annual net sales from pipeline assets (NAS
Slide 12: Lead Asset Anaphylm (epinephrine) Sublingual Film
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc.12 Lead Asset AnaphylmTM (epinephrine) Sublingual Film
Slide 13: Anaphylaxis: a potentially fatal allergic reaction
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc.13 Anaphylaxis: a potentially fatal allergic reaction1 1Turner PJ, et al. World Allergy Org J. 2019;12100066 Anaphylaxis is a severe systemic hypersensitivity allergic reaction that is rapid in onset and can ca
Slide 14: Stages of anaphylaxis: earlier intervention is critical
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Stages of anaphylaxis: earlier intervention is critical 14 1Dribin et al., J Allergy Clin Immunol, 2021; Xu et al., Allergy Asthma Clin Immunol. 2014 Skin Grade 1 Grade 2-3 Grade 4 Grade 5 Skin Gastro-Intestin
Slide 15: Treatment of Anaphylaxis: epinephrine
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Treatment of Anaphylaxis: epinephrine1 15 • Epinephrine, the only medication proven to stop a life-threatening allergic reaction, is the first-line treatment for anaphylaxis • All devices currently on the mark
Slide 16: The numbers on Anaphylaxis
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. The numbers on Anaphylaxis 16 At chronic risk for acute anaphylactic episodes in the United States1 1FARE, 2022; https://www.foodallergy.org/resources/facts-and-statistics; 2Fromer L. The American Journal of M
Slide 17: Epinephrine market continues to grow
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Epinephrine market continues to grow1 17 3,164 3,260 3,048 3,975 4,000 4,671 4,671 2018 - 2020 15% CAGR 2021 - 2023 2018A 2019A 2020A 2021A 2022A 2023A 2024E 2018-2020 Baseline CAGR Epinephrine Market TRx Volu
Slide 18: High levels of dissatisfaction combined with unmet need
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. High levels of dissatisfaction combined with unmet need 18 1.KOL feedback; Aquestive Market Research.; 2Warren et al. Ann Allergy Asthma Immunol (2018).; 3Brooks et al. Ann Allergy Asthma Immunol (2017).; 4Ast
Slide 19: Anaphylm (epinephrine) Sublingual Film
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Anaphylm (epinephrine) Sublingual Film 19 + + The first and only non-device based, orally delivered epinephrine product candidate Portability Non-device administration Fast absorption into the bloodstream
Slide 20: Anaphylm Pivotal Study Meets Primary & Secondary Endpoints
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc.20 Anaphylm Pivotal Study Meets Primary & Secondary Endpoints
Slide 21: Anaphylm program overview
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Anaphylm program overview 21 i dicines. l i r le s. I i li s. Pivotal Study meets endpoints for single dose and repeat dose Positive FDA Type C meeting provides clarity on path to filing Continue to anticipate
Slide 22: Anaphylm is fast-acting and well-tolerated
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Anaphylm is fast-acting and well-tolerated, with a safety profile comparable to standard of care (SOC) 1 22 1 2 3 Rapid absorption as demonstrated by: Local adverse events (AE’s) were generally mild (1 moderat
Slide 23: Anaphylm 12mg single dose study meets primary endpoints of Cmax
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Anaphylm 12mg single dose study meets primary endpoints of Cmax, demonstrating comparability to current SOC1 23 Primary endpoints predefined as Anaphylm values bracketed between injectable products for (1) Max
Slide 24: Anaphylm meets secondary endpoint of AUC
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Anaphylm meets secondary endpoint of AUC, demonstrating biocomparability to the current SOC1 24 Geometric Mean Epinephrine Exposure Levels (pAUC) by Product After a Single Dose 5 10 15 20 25 30 35 40 45 50 55
Slide 25: Anaphylm matches and surpasses EAI
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Anaphylm matches and surpasses EAI: concentration remains above 100 pg/mL at 60 minutes after dosing1 25 Geometric Mean Epinephrine Concentrations by Product After a Single Dose ● Similar to autoinjectors, Ana
Slide 26: Time to maximum concentration more consistent than autoinjectors
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Time to maximum concentration of Anaphylm significantly more consistent compared to autoinjectors1 26 Time Post-Dosing to Maximum Concentration of Epinephrine ● Tmax is a surrogate for speed of absorption, a c
Slide 27: Anaphylm quickly addresses drop in heart rate and blood pressure
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Anaphylm quickly addresses drop in heart rate and blood pressure1 27 Manual IMAnaphylmEpiPenAuvi-Q Median Change in Systolic Blood Pressure Over Time -5 0 5 10 15 20 SB P (m m H g) 0 30 60 90 120 150 180 210 2
Slide 28: Expected clinical timeline for Anaphylm
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Expected clinical timeline for Anaphlym 28 Temperature /pH study Self administration study Allergen challenge study Pediatric study FDA Type C Meeting Completed Pivotal Study Completed Q1 2024 Q2 2024 Q3 2024
Slide 29: Pipeline Products
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc.29 Pipeline Products
Slide 30: Libervant (diazepam) buccal film path to launch
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. Libervant (diazepam) buccal film path to launch 30 Libervant (ages 12 and up) • Currently anticipate receiving FDA approval in January 2027 PDUFA Date • December 23, 2021 Tentative approval received • August 3
Slide 31: AQST-108 (epinephrine) prodrug topical gel
Advancing medicines. Solving problems. Improving lives. AQST-108 (epinephrine) prodrug topical gel 31 Human Skin Structure • Topical delivery of epinephrine has been limited due to poor permeability and rapid clearance1 • Adrenaverse prodrug platform allows for the targeted delivery of epinephrine w
Slide 32: Financial Guidance
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc.32 Financial Guidance
Slide 33: 2024 Outlook
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc. 2024 outlook as of May 7, 2024 33 Total revenues of approximately $48 to $51 million Non-GAAP adjusted EBITDA loss of approximately $22 to $26 million Cash runway extended into 2026 with completion of $77.5 mi
Slide 34: Thank You
Advancing medicines. Solving problems. Improving lives. ©2024 Aquestive Therapeutics, Inc.34 Thank You
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