Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Investor Presentation (August 2025)
26 slides from Aquestive Therapeutics's investor presentation, Aug 15, 2025
Slide 1: Project Academy Corporate Presentation
Project Academy Corporate Presentation Strictly Confidential. Do Not Distribute.
Slide 2: Disclaimer
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 Reform Act of 1995. Words such as “believe,
Slide 3: Who we are
A publicly traded pharmaceutical company (NASDAQ: AQST) focused on advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. Who we are… Strictly Confidential. Do Not Distribute.
Slide 4: Company key facts
6 of revenue in 2024 150+ 20+ years since the company was founded Products available in 6 continents drug approvals 2.5 billion $57M+ PharmFilm® doses shipped worldwide More than employees based in Indiana and New Jersey expected in the U.S. by 2027 if approved by the FDA 2 product launches 4 Strict
Slide 5: Our Technologies
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 a
Slide 6: Go-to formulation development and commercial manufacturing partner for oral thin film
Aquestive is the go-to formulation development and commercial manufacturing partner for oral thin film products worldwide Our Products 1. Ondif collaboration with Hypera-Pharma (Brazil). 2. Sympazan collaboration with Otter Pharmaceuticals (worldwide). 3. Emylif collaboration with Zambon (EU). 4. Su
Slide 7: Diversified Pipeline Fuels Our Growth Plan
Anaphylm™ (epinephrine) 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 Proprietary Growth
Slide 8: Dedicated and Experienced Leadership Team
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 C
Slide 9: Revenue Interest Purchase and Sales Agreement
Revenue Interest Purchase and Sales Agreement Strictly Confidential. Do Not Distribute.
Slide 10: $75M revenue interest purchase and sale agreement with RTW affiliate
An affiliate of RTW (the “Purchaser”) has agreed to enter into a $75M revenue interest purchase and sale agreement (the “RIPSA”) with Aquestive with substantially the following terms: Funding is contingent upon both FDA approval of Anaphylm (with a January 31, 2026 scheduled PDUFA date) and refinanc
Slide 11: Lead Asset Anaphylm (epinephrine) Sublingual Film
Lead Asset Anaphylm™ (epinephrine) Sublingual Film Strictly Confidential. Do Not Distribute.
Slide 12: A Novel Approach to Epinephrine Delivery
A Novel Approach to Epinephrine Delivery First and only non-device based, orally delivered epinephrine product candidate Needle-Free Easy to Administer Delay-Free Designed to Work Quickly1 Device-Free Easy to Carry + + Anaphylm™ (epinephrine) Sublingual Film 1. Aquestive Therapeutics data on file. S
Slide 13: Anaphylaxis: A rapid-onset, life-threatening allergic reaction
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.2019
Slide 14: Anaphylaxis is on the Rise—and so are the Risks
Anaphylaxis is on the Rise—and so are the Risks 1. Gupta RS, et al. Pediatrics. 2011. 2. Gupta RS, et al. Pediatrics 2018. 3. McGowan EC, et al. J Clin Allergy Immunol. 2013. 4. Jackson KD, et al. NCHS Data Brief. 2013. 5. Black LI, et al. CDC National Center for Health Statistics Data Brief. 2019.
Slide 15: U.S. Market has the Potential to Grow to ~$2B in Value by 2031
U.S. Market has the Potential to Grow to ~$2B in Value by 20311 Current Market Size (2024)²:~$800M Projected Market Size (2031):Over $1B 1. Aquestive Therapeutics data on file, scripts written for epinephrine auto-injectors(EAIs) have increased at a 15% compound annual growth rate (CAGR) from 2021-
Slide 16: Top Reasons Why People Don't Carry Epinephrine Autoinjectors
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 carryi
Slide 17: Rapid Relief Needed When It Matters Most
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 T-max of 12 minutes 1. Aquestive Therapeutics, Inc. data results on file, excludi
Slide 18: Film Dosing Option Preference – Patients and HCPs
Film Dosing Option Preference – Patients and HCPs1 80% prefer a non-injection dosing method 95% are interested in a film-dosing option PATIENTS AND CAREGIVERS 95% believe a film-dosing option fills an unmet need in the epinephrine market 85% indicated they would Rx a film-dosing option HEALTHCARE PR
Slide 19: Anaphylm Anticipated Key Milestones
Anaphylm Anticipated Key Milestones Pediatric Study Completed Q1 2025 NDA Submission Completed NDA Accepted by the FDA Potential Advisory Committee Meeting Q2 2025 Q3 2025 Q4 2025 Q1 2026 PDUFA action date is scheduled for January 31, 2026 Strictly Confidential. Do Not Distribute.
Slide 20: Anaphylm completed and planned go-to-market activities
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 Readiness Conti
Slide 21: Pipeline Products
Pipeline Products Strictly Confidential. Do Not Distribute.
Slide 22: AQST-108 (epinephrine) Topical Gel
AQST-108 (epinephrine) Topical Gel 1. Jeong, W.Y., Kwon, M., Choi, H.E. et al. Recent advances in transdermal drug delivery systems: a review. Biomater Res 25, 24 (2021). 2. Aquestive Therapeutics data on file. 3. See Investor Day Presentation dated September 27, 2024, located at Aquestive.com/inves
Slide 23: Alopecia Areata Represents a Potentially Significant Opportunity
Alopecia Areata Represents a Potentially Significant Opportunity¹ REASONS TO BELIEVE Patient unmet need is well-documented and understood Planned development endpoints that are potentially achievable Competitive landscape indicates pricing should continue to be reasonable Commercial opportunity can
Slide 24: AQST-108 Planned Phase 2a Clinical Study for Alopecia Areata
AQST-108 Planned Phase 2a Clinical Study for Alopecia Areata¹ Phase 2a Study Design 36 subjects, 3 doses 12 – 24 weeks² Early Responder Rate (ERR) of 10% - early responder defined as a subject with 20% improvement in Severity of Alopecia Tool (SALT)³ from baseline at week 12 Proportion of subjects a
Slide 25: Planned AQST-108 Clinical and Regulatory Approval Timeline
Planned AQST-108 Clinical and Regulatory Approval Timeline Q4 2025 Q1 2026 Q2 2026 Q3 2026 Expect to Open IND Expected Initiation of Phase 2a Strictly Confidential. Do Not Distribute.
Slide 26: Thank You
Thank You Strictly Confidential. Do Not Distribute.
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