Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Investor Presentation (September 2024)
47 slides from Aquestive Therapeutics's investor presentation, Sep 9, 2024
Slide 1: Corporate Presentation September 2024
Advancing medicines. Solving problems. Improving lives. 1 Advancing medicines. Solving problems. Improving lives. Corporate Presentation September 2024
Slide 2: Disclaimer
Disclaimer 2 © 2024 Aquestive Therapeutics, Inc. 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
Advancing medicines. Solving problems. Improving lives. 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 innovative science and delivery technolo
Slide 4: Drug delivery technologies: PharmFilm and Adrenaverse
Advancing medicines. Solving problems. Improving lives. PharmFilm® 4 Drug delivery technologies AdrenaverseTM Prodrug Platform Adrenaverse platform contains a library of over 20 epinephrine prodrugs that demonstrate control of absorption and conversion rates across a variety of dosage forms and deli
Slide 5: PharmFilm validation from commercial products
PharmFilm® Validation from 5 proprietary and licensed commercial products, supplying over 95% of the world’s prescription oral thin films 5 Aquestive is the go-to formulation development and commercial manufacturing partner for oral thin film products worldwide 1. Ondif collaboration with Hypera-Pha
Slide 6: Diversified pipeline
Diversified pipeline 6 1. Annual revenue includes revenue for patients 12 and up after launch in 2027. 2. Aquestive Therapeutics data on file.
Slide 7: Growth plan
Advancing medicines. Solving problems. Improving lives. Growth plan 7 1. Assumes satisfaction of all predetermined clinical endpoints and approved by U.S. Food and Drug Administration (FDA). 2. Estimate is based on an orphan drug market exclusivity block until January of 2027 by an FDA approved nasa
Slide 8: Our end-to-end capabilities
● 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 capabilities 8 Development Production Commercialization ● Leading manufacturer of oral thin f
Slide 9: Financial snapshot
Financial snapshot 9 (25.0) (20.0) (15.0) (10.0) (5.0) 0.0 5.0 2019 2020 2021 2022 2023 U S D m il li o n s EBITDA excluding R&D by Year - 5.0 10.0 15.0 20.0 25.0 2019 2020 2021 2022 2023 U S D m il li o n s R&D Investment by Year - 10.0 20.0 30.0 40.0 50.0 60.0 2019 2020 2021 2022 2023 U S D m il l
Slide 10: Dedicated and experienced leadership team
Dedicated and experienced leadership team 10 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 Mark Schobel Chief Innovation & Technology Officer Cassie Jung Chief Ope
Slide 11: Company key facts
6 $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 billion1 in potential peak annual net sales from pipeline assets (NASDAQ: AQST) 2
Slide 12: Anaphylaxis and Unmet Needs
12 Anaphylaxis and Unmet Needs
Slide 13: Anaphylaxis: a potentially fatal allergic reaction
Advancing medicines. Solving problems. Improving lives. Anaphylaxis: a potentially fatal allergic reaction1 1. Turner PJ, et al. World Allergy Org J. 2019;12100066. Severe systemic hypersensitivity allergic reaction that is rapid in onset and can cause death Poses serious consequences for at-risk pa
Slide 14: Stages of anaphylaxis: early intervention is critical
Stages of anaphylaxis: early intervention is critical 1 14 1. Dribin et al., J Allergy Clin Immunol, 2021; Xu et al., Allergy Asthma Clin Immunol. 2014. Skin Mild Moderate Severe Life-Threatening Skin Gastrointestinal Skin Gastrointestinal Respiratory Cardiovascular Skin Gastrointestinal Respiratory
Slide 15: What is happening in the allergy rescue space
Advancing medicines. Solving problems. Improving lives. 15 What is happening in the allergy rescue space • Epinephrine, the only medication proven to stop a life-threatening allergic reaction, is the first-line treatment for anaphylaxis • No oral products are available • By nature, EMDs would be put
Slide 16: Several factors influence epinephrine administration during anaphylaxis
Several factors influence epinephrine administration during anaphylaxis 16 • Comorbidities • Rhinitis: 10% - 30%1,2 • Chronic rhinosinusitis: 12%3 • Mental issues • Needle phobia: 50%4,5,6 • Anaphlym has the potential to address these issues: • Orally administered – not affected by rhinitis • No nee
Slide 17: U.S. market has the potential to grow to ~$2B by 2031
Advancing medicines. Solving problems. Improving lives. 17 U.S. market has the potential to grow to ~$2B in value by 20311 1. Aquestive Therapeutics data on file, scripts written for epinephrine autoInjectors have increased at a 15% compound annual growth rate (CAGR) from 2021- 2023. 2. https://food
Slide 18: Lead Asset Anaphylm (epinephrine) Sublingual Film
18 Lead Asset AnaphylmTM (epinephrine) Sublingual Film
Slide 19: Executive Summary
Large Market Opportunity Novel Oral Product Path to Launch • ~$2B anaphylaxis market in value by 2031 with high unmet meet1 • First and only oral epinephrine product candidate in development for anaphylaxis, with patent protection potentially into 2044 • World leader in oral thin film delivery, with
Slide 20: Anaphylm (epinephrine) sublingual film
Anaphylm (epinephrine) sublingual film + + Easy To Carry Easy To Administer Works Quickly1 20 1. Aquestive Therapeutics data on file. First and only non-device based, orally delivered epinephrine product candidate
Slide 21: Most common reasons people don't carry their epinephrine devices
Advancing medicines. Solving problems. Improving lives. Most common reasons that people don’t carry their epinephrine medical devices (EMDs)1 • Inconvenience • Forgetfulness • Cost • Availability at other places, such as the home, car or school • Expiration of the previous prescription • Complacency
Slide 22: Incorporating Anaphylm into patients' daily lifestyle routine
Incorporating Anaphylm into patients’ daily lifestyle routine 75% of Americans feel uneasy leaving their phone at home1 22 1. https://www.reviews.org/mobile/cell-phone-addiction; July 2023. Anaphlym, if approved by the FDA, has the potential to be carried on the back of a phone. 71% experience stres
Slide 23: High epinephrine prescribing physicians have spoken
High epinephrine prescribing physicians have spoken1 23 expressed concern that their at-risk patients don’t consistently have an epinephrine auto injector (EAI) with them when away from home~90% articulated that “A sublingual film is more likely to be carried, thereby protecting more at-risk patient
Slide 24: Patients and caregivers have spoken
Patients and caregivers have spoken1 24 1. Aquestive Therapeutics 2024 Survey data on file.
Slide 25: Intellectual Property
<< Aquestive’ Intellectual Property
Slide 26: Anaphylm patent portfolio
ANAPHYLM Patent Title Status ENHANCED DELIVERY EPINEPHRINE COMPOSITIONS ► 2 US patents granted ► 2 US applications ► 3 Foreign patents ► 8 Foreign applications ► Priority date: May 5, 2016 ► Possible patent term to 2037 ENHANCED DELIVERY EPINEPHRINE AND PRODRUG COMPOSITIONS ► 2 US applications ► 8 F
Slide 27: Anaphylm Clinical Program
27 Anaphylm Clinical Program
Slide 28: Program overview
Program overview 28 Pivotal Study meets predetermined endpoints for single dose and repeat dose Temperature/pH Study and Self-Administration Study meet predetermined endpoints; Oral Allergy Syndrome Study underway Continue to anticipate a pre-NDA meeting with FDA prior to filing
Slide 29: Fast-acting and well-tolerated, safety comparable to standard of care
Fast-acting and well-tolerated, with a safety profile comparable to standard of care (SOC)1 29 1 2 3 Rapid absorption as demonstrated by: Consistent pharmacokinetics (PK) demonstrated across 5 administration procedures: Consistent time to peak drug concentration (Tmax) of 12-15 minutes Onset of phar
Slide 30: Anaphylm Pivotal Study Results
30 Anaphylm Pivotal Study Results
Slide 31: 12mg single dose study meets primary endpoints of Cmax
12mg single dose study meets primary endpoints of Cmax, demonstrating biocomparability to current SOC1 31 Primary endpoints predefined as Anaphylm values bracketed between injectable products for (1) maximum drug concentration (Cmax) and (2) area under the curve (AUC)0-10min, AUC0-20min, AUC0-30min,
Slide 32: Primary predetermined endpoint of pAUC met
Primary predetermined endpoint of pAUC, demonstrating biocomparability to SOC to the current SOC is met1 32 Geometric Mean Epinephrine Exposure Levels (pAUC) by Product After a Single Dose 5 10 15 20 25 30 35 40 45 50 55 60 0 50 100 150 200 250 300 Time Post-Dose, min P a rt ia l A U C ( h r* p g /m
Slide 33: Anaphylm demonstrated a rapid and robust PK profile
Anaphylm demonstrated a rapid and robust PK profile1 33 Geometric Mean Epinephrine Concentrations by Product After a Single Dose Anaphylm’s epinephrine concentration: ● Exceeds Adrenalin beginning at 2 minutes ● Matches EAI’s by 10 minutes ● Sustains levels above Adrenalin intramuscular out to 35 mi
Slide 34: Time to maximum concentration more consistent
Time to maximum concentration of Anaphylm demonstrates more consistency1 34 Time Post-Dosing to Maximum Concentration of Epinephrine ● Tmax is a surrogate for speed of absorption, a critical factor in treating Anaphylaxis ● Tmax consistency is an important measure of clinical performance ● Anaphylm
Slide 35: Anaphylm demonstrates rapid pharmacodynamic effects
Anaphylm demonstrates rapid pharmacodynamic (PD) effects1 35 Manual IMAnaphylmEpiPenAuvi-Q Median Change in Systolic Blood Pressure Over Time -5 0 5 10 15 20 S B P ( m m H g ) 0 30 60 90 120 150 180 210 240 Time (minutes) Median Change in Diastolic Blood Pressure Over Time 0 30 60 90 120 150 180 210
Slide 36: Supportive Studies and Clinical Timeline
36 Supportive Studies and Clinical Timeline
Slide 37: Temperature/pH study results
Temperature/pH study results1 37 1. Aquestive Therapeutics data on file. Test Condition Cmax (Test Condition/Room Temperature Water) AUC0-60min (Test Condition/Room Temperature Water) Cold water 106% 98% Hot water 104% 107% Lemon water (target pH: 3) 98% 99% Baking soda water (target pH:8) 123% 132%
Slide 38: Temperature/pH study pharmacodynamic results
Temperature/pH study pharmacodynamic (PD) results1 38 Key Takeaways: ● Topline results demonstrate no statistically significant difference in the maximum increase in systolic blood pressure due to temperature/pH conditions ● PD results for this study are in alignment with prior study results Median
Slide 39: Self-administration PK study results
Self-administration PK study results1 39 1. Aquestive Therapeutics data on file. Key Takeaways: ● Cmax was not statistically different whether Anaphylm was self-administered or administered by an HCP ● Median Tmax was 15 minutes for Anaphylm whether self-administered or administered by an HCP ● Medi
Slide 40: Self-administration study PD results
Self-administration study PD results1 40 Key Takeaways: ● Topline PD results demonstrate no significant difference in the median increase in systolic blood pressure whether Anaphylm is self-administered or HCP-administered ● PD results for this study are in alignment with prior study results Median
Slide 41: Expected clinical timeline for Anaphylm
Expected clinical timeline for Anaphlym 41 Q2 2024 Q3 2024 Q4 2024 Q1 2025 Temperature/pH Study Completed Oral Allergy Syndrome (OAS) Study Self-Administration Study Completed Pre-NDA Meeting File NDA Pediatric Study
Slide 42: Pipeline Products
<< Aquestive’ Pipeline Products
Slide 43: Expected full launch path for Libervant buccal film
Expected full launch path for Libervant (diazepam) buccal film 43 Libervant (for patients ages six and up) • Currently anticipate receiving full FDA approval in January 2027 • Plan to launch for ages six to eleven years, if approved by FDA PDUFA Date • December 23, 2021 Tentative FDA approval receiv
Slide 44: AQST-108 (epinephrine) topical gel
AQST-108 (epinephrine) topical gel 44 Human Skin Structure • Topical delivery of epinephrine has been limited due to poor permeability and rapid clearance 1 • Adrenaverse prodrug platform demonstrates targeted delivery of epinephrine without systemic effects² • First human study completed • IND-enab
Slide 45: Financial Guidance
<< Aquestive’ Financial Guidance
Slide 46: 2024 Outlook
2024 expected outlook as of August 6, 2024 46 Total revenues of approximately $57 to $60 million Non-GAAP adjusted EBITDA loss of approximately $20 to $23 million Cash runway extended into 2026 with completion of $77.5 million underwritten public offering with high quality institutional healthcare i
Slide 47: Thank You
<< Aquestive’ Thank You
Aquestive Therapeutics — Investor Presentation (September 2024) on 6ix