Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Investor Presentation (August 2025)
25 slides from Aquestive Therapeutics's investor presentation, Aug 11, 2025
Slide 1: Corporate Presentation August 2025
Advancing medicines. Solving problems. Improving lives. September 2024 Corporate Presentation August 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: Who we are
3 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…
Slide 4: 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 5: Our Technologies
5 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 6: Our Products
6 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.
Slide 7: Diversified Pipeline Fuels Our Growth Plan
7 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 1. Aquestive Ther
Slide 8: Dedicated and Experienced Leadership Team
8 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 9: Lead Asset Anaphylm (epinephrine) Sublingual Film
Lead Asset Anaphylm (epinephrine) Sublingual Film
Slide 10: A Novel Approach to Epinephrine Delivery
10 A Novel Approach to Epinephrine Delivery First and only non-device based, orally delivered epinephrine product candidate Needle-Free Easy to Administer Delay-Free Works Quickly1 Device-Free Easy to Carry + + Anaphylm (epinephrine) Sublingual Film 1. Aquestive Therapeutics data on file.
Slide 11: Anaphylaxis: A rapid-onset, life-threatening allergic reaction
11 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 12: Anaphylaxis is on the Rise—and so are the Risks
12 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. 201
Slide 13: U.S. Market has the Potential to Grow to ~$2B by 2031
13 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 15% CAGR from 2021 to 2023 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 202
Slide 14: Top Reasons Why People Don't Carry Epinephrine Autoinjectors
14 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 15: Rapid Relief When It Matters Most
15 Rapid Relief When It Matters Most1 Anaphylm reaches peak absorption in just 12 minutes Achieves therapeutic blood concentrations in as little as 5 minutes (over 100 pg/ml) Consistently delivers a median T-max of 12 minutes 1. Aquestive Therapeutics, Inc. data results on file, excluding T-max data
Slide 16: Film Dosing Option Preference – Patients and HCPs
16 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 17: Anaphylm Key Milestones
17 Anaphylm Key Milestones Pediatric Study Completed Q1 2025 NDA Submission Completed NDA Accepted by the FDA Potential ex-US Approval Filings Potential Advisory Committee Meeting Q2 2025 Q3 2025 Q4 2025 Q1 2026 PDUFA action date is scheduled for January 31, 2026
Slide 18: Anaphylm go-to market activities
18 2024 2025 2026 Anaphylm 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 • Continue to incr
Slide 19: Pipeline Products
| ff << Aquestive’ Pipeline Products
Slide 20: AQST-108 (epinephrine) Topical Gel
20 z 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/
Slide 21: Alopecia Areata Represents a Potentially Significant Opportunity
21 Alopecia Areata Represents a Potentially Significant Opportunity¹ R E A S O N S T O B E L I E V E Patient unmet need is well- documented and understood Planned development endpoints that are potentially achievable Competitive landscape indicates pricing will continue to be reasonable Commercial o
Slide 22: Olumiant and Litfulo Prescriptions by Quarter
22 120% Annual Growth Estimated $1 billion+ opportunity for JAK inhibitors¹ 6k 9k 13k 15k 18k 21k 23k 26k 29k - 5,000 10,000 15,000 20,000 25,000 30,000 2022-Q2 2022-Q3 2022-Q4 2023-Q1 2023-Q2 2023-Q3 2023-Q4 2024-Q1 2024-Q2 P R E S C R IP T IO N C O U N T Olumiant and Litfulo Prescriptions by Quart
Slide 23: AQST-108 Planned Phase 2a Clinical Study for Alopecia Areata
23 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 subject
Slide 24: Planned AQST-108 Clinical and Regulatory Approval Timeline
24 Planned AQST-108 Clinical and Regulatory Approval Timeline Q4 2025 Q1 2026 Q2 2026 Q3 2026 Expect to Open IND Expected Phase 2bExpected Phase 2a
Slide 25: Thank You
| ff << Aquestive’ Thank You
Aquestive Therapeutics — Investor Presentation (August 2025) on 6ix