Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — H.C. Wainwright 27th Annual Global Investment Conference 2025
25 slides from Aquestive Therapeutics's conference presentation, Sep 8, 2025
Slide 1: Advancing medicines. Solving problems. Improving lives.
Advancing medicines. Solving problems. Improving lives. September 2024 H.C. Wainwright 27th Annual Global Investment Conference September 8, 2025
Slide 2: Disclaimer
© 2025 Aquestive Therapeutics, Inc. 2 Disclaimer 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 the meaning of the Private Securities Litigation Refor
Slide 3: Aquestive at a glance
6 of revenue in 2024 150+ 20+ years since the company was founded Products available in6 continents Over $1.5 billion1 in potential peak annual net sales from pipeline assets drug approvals 1.Aquestive Therapeutics data on file. 2.5 billion $57M+ PharmFilm® doses shipped worldwide More than employee
Slide 4: Our Technologies
4 Our Technologies AdrenaVerseTM platform contains a library of over 20 epinephrine prodrugs that demonstrate control of absorption and conversion rates across a variety of dosage forms including lotions, creams, and ointments (LCOs) and delivery sites. The AdrenaVerse platform enables us to pursue
Slide 5: Diversified Pipeline Fuels Our Growth Plan
5 Anaphylm (dibutepinephrine) Sublingual Film (SEVERE ALLERGIES, ANAPHYLAXIS) PDUFA action date is scheduled for January 31, 2026 Libervant® (diazepam) Buccal Film (ACUTE REPETITIVE SEIZURES) AQST-108 (epinephrine) Topical Gel (ALOPECIA AREATA) Diversified Pipeline Fuels Our Growth Plan 1. Aquestive
Slide 6: Dedicated and Experienced Leadership Team
6 Cassie Jung Chief Operating Officer Dedicated and Experienced Leadership Team Daniel Barber President, CEO & Director Lori J. Braender Chief Legal Officer, Chief Compliance Officer, Corporate Secretary Ernie Toth Chief Financial Officer Peter Boyd SVP, HR & IT Melina Cioffi SVP, Regulatory Affairs
Slide 7: Anaphylm Potential Key Milestones
7 Anaphylm Potential Key Milestones Pediatric Study Completed Q1 2025 NDA Submission Completed NDA Accepted by the FDA Potential ex-US Approval Filings Q2 2025 Q3 2025 Q4 2025 Q1 2026 PDUFA action date scheduled for January 31, 2026
Slide 8: U.S. Market has the Potential to Grow to ~$2B in Value by 2031
8 U.S. Market has the Potential to Grow to ~$2B in Value by 20311 Current Market Size (2024)²: ~$800M Projected Market Size (2031): ~$2B 3,164 3,260 3,048 3,975 4,000 4,671 4,940 0 500 1,000 1,500 2,000 2,500 3,000 3,500 4,000 4,500 5,000 2018A 2019A 2020A 2021A 2022A 2023A 2024A Epinephrine Market
Slide 9: Recent capital raise activities validate the belief in the commercial promise of Anaphylm
9 Recent capital raise activities validate the belief in the commercial promise of Anaphylm On August 14, 2025, we completed an equity raise of $85 million We further bolstered our balance sheet with a strategic funding with RTW Investments, LP Equity raise and strategic funding provide cash runway
Slide 10: Lead Asset Anaphylm (dibutepinephrine) Sublingual Film
10 Lead Asset Anaphylm (dibutepinephrine) Sublingual Film
Slide 11: A Novel Approach to Epinephrine Delivery
11 A Novel Approach to Epinephrine Delivery First and only non-device based, orally delivered epinephrine product candidate Needle-Free Easy to Use Designed to Work Quickly1 Device-Free Easy to Carry + + Anaphylm (dibutepinephrine) Sublingual Film 1. Aquestive Therapeutics, Inc. data on file.
Slide 12: Top Reasons Why People Don't Carry Epinephrine Autoinjectors
12 Top Reasons Why People Don’t Carry Epinephrine Autoinjectors (EAI) Devices1 1. https://community.kidswithfoodallergies.org/blog/new-epinephrine-study-shows-alarming-results; survey results reflect EAIs only. 2.Fromer L., The American Journal of Medicine (2016) 129, 1244-1250. Inconvenience of car
Slide 13: Anaphylaxis: A rapid-onset, life-threatening allergic reaction
13 Anaphylaxis: A rapid-onset, life-threatening allergic reaction requiring immediate intervention 1. Xiaowei Liu , Sangil Lee , Christine M Lohse , Cassandra T Hardy , Ronna L Campbell Biphasic Reactions in Emergency Department Anaphylaxis Patients: A Prospective Cohort Study, DOI: 10.1016/j.jaip.2
Slide 14: Rapid Relief Needed When It Matters Most
14 Rapid Relief Needed When It Matters Most1 Anaphylm reaches peak absorption in just 12 minutes Observed to achieve therapeutic blood concentrations in as little as 5 minutes (over 100 pg/ml) Observed to deliver a median Tmax of 12 minutes 1. Aquestive Therapeutics, Inc. data results on file, exclu
Slide 15: Film Dosing Option Preference – Patients and HCPs
15 Film Dosing Option Preference – Patients and HCPs1 80% prefer a non-injection dosing method 95% are interested in a film-dosing option P A T I E N T S A N D C A R E G I V E R S 95% believe a film-dosing option fills an unmet need in the epinephrine market 85% indicated they would Rx a film-dosing
Slide 16: Anaphylm Commercial Opportunity and Readiness
16 Anaphylm Commercial Opportunity and Readiness
Slide 17: Anaphylm completed and planned go-to-market activities
17 2024 2025 2026 Anaphylm completed and planned go-to market activities Strategic Foundations • Key opinion leader engagement • Market research with >1,000 HCPs, patients, caregivers, and payors • Partnering with epinephrine- experienced promotional agencies and commercial consultants Launch Readin
Slide 18: Planned Anaphylm launch strategy
18 Reminder: Planned Anaphylm launch strategy Focus on driving awareness among allergists and pediatricians1 2 3 4 Launch into the “warm weather” volume increase Price within the range of existing standards of care Leverage our existing commercial know-how
Slide 19: Epinephrine prescribers: an addressable market opportunity
19 Epinephrine prescribers: an addressable market opportunity1 • Allergists are the most productive segment by far, averaging ~200 prescriptions per year • Pediatricians are the second most productive segment, averaging ~16 prescriptions per year 1. Aquestive Therapeutics, Inc. data on file.
Slide 20: Launch into the "warm weather" volume increase
20 Launch into the “warm weather” volume increase1 1. Aquestive Therapeutics, Inc. data on file; all market data is limited to U.S. and its Territories.
Slide 21: Bridging from Awareness to Filled Prescriptions
21 Bridging from Awareness to Filled Prescriptions
Slide 22: Market Access: the foundation to a successful Anaphylm launch
22 Market Access: the foundation to a successful Anaphylm launch Strictly Confidential. Do Not Distribute. Current areas of Aquestive diligence and focus
Slide 23: Trade & Distribution Strategy
23 Trade & Distribution Strategy • Vertically integrated operations with supply chain infrastructure prepared for launch and scalable growth • Strategic distribution relationships secured through established wholesaler agreements and third-party logistics contracts • Multi-channel distribution strat
Slide 24: Patient Services Strategy
24 Patient Services Strategy Strictly Confidential. Do Not Distribute. • Best-in-class patient services deployment • Access and affordability optimization • Patient and provider support • Scalable solutions
Slide 25: Thank You
Thank You 6 Aquestive =
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