Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Investor Presentation (August 2022)
24 slides from Aquestive Therapeutics's investor presentation, Aug 3, 2022
Slide 1: Aquestive Therapeutics Corporate Presentation
Advancing medicines. Solving problems. Improving lives. Advancing medicines. Solving problems. Improving lives. August 2022 Aquestive Therapeutics Corporate Presentation
Slide 2: Forward-Looking Statement
Advancing medicines. Solving problems. Improving lives. ® Forward-Looking Statement This presentation includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “anticipate,” “plan,” “expect,” “estimate,” “intend,” “may,”
Slide 3: Our Path
Advancing medicines. Solving problems. Improving lives. Our Path Proven track record of success • Technology-based pharmaceutical company • 5 FDA-approved products • 10+ years of product sales • 200+ patents worldwide 3 Near-term pipeline catalysts • AQST-109 Epinephrine Sublingual Film ‒ First and
Slide 4: PharmFilm Technology – Where You Need It, When You Need It
Advancing medicines. Solving problems. Improving lives. PharmFilm® Technology – Where You Need It, When You Need It™ 4
Slide 5: Our Team
Advancing medicines. Solving problems. Improving lives. Our Team Daniel Barber President, CEO and Director Peter Boyd SVP, Business Process & Information Technology Lori J. Braender General Counsel and Chief Compliance Officer Ken Marshall Chief Commercial Officer Mark Schobel Chief Innovation & Tec
Slide 6: Our Products
Advancing medicines. Solving problems. Improving lives. Our Products AQST-108 Sublingual Film (Epinephrine) (Alternative Indications) AQST-109 Sublingual Film (Epinephrine) (Anaphylaxis) Proprietary growth drivers Preclinical Clinical Filed Marketed FDA Approved 2010 Suboxone® Sublingual Film (Bupre
Slide 7: AQST-109: Reimagining How to Treat Anaphylaxis
Advancing medicines. Solving problems. Improving lives. AQST-109: Reimagining How to Treat Anaphylaxis 7
Slide 8: Anaphylaxis: A Serious Systemic Hypersensitivity Reaction
Advancing medicines. Solving problems. Improving lives. Anaphylaxis: A Serious Systemic Hypersensitivity Reaction That is Usually Rapid in Onset And May Be Fatal1 As many as 49 million people in the United States are at chronic risk for acute anaphylactic episodes2 Lifetime prevalence may be higher
Slide 9: Epinephrine Auto-injectors, The Current Standard of Care, Are Challenging
Advancing medicines. Solving problems. Improving lives. Epinephrine Auto-injectors, The Current Standard of Care, Are Challenging Patients and caregivers using epinephrine auto-injectors often experience fear, anxiety, and needle phobia1,2 – Needle fear has been reported in 68% of children aged 6 to
Slide 10: AQST-109: Potential to Solve These Issues
Advancing medicines. Solving problems. Improving lives. AQST-109: Potential to Solve These Issues AQST-109 is the first and only orally delivered epinephrine product candidate for the treatment of allergic reactions (type 1), including anaphylaxis, that would allow patients and their providers to: 1
Slide 11: AQST-109: PK Values Comparable to Existing Epinephrine Auto-injectors in Part 2 of EPIPHAST
Advancing medicines. Solving problems. Improving lives. AQST-109: Pharmacokinetic (PK) Values Comparable to Existing Epinephrine Auto-injectors in Part 2 of EPIPHAST Trial 11 • Favorable time to maximum concentration (Tmax) • Partial area under the curve (AUC) out to 30 minutes Description† AQST-109
Slide 12: AQST-109: PD Values Compared Favorably to Epinephrine Auto-injectors
Advancing medicines. Solving problems. Improving lives. AQST-109: Pharmacodynamic (PD) Values Compared Favorably to Epinephrine Auto-injectors in Part 2 of EPIPHAST Trial 12 “ “ • Administration of epinephrine is known to cause an increase in systolic blood pressure over time • Quantifying the incre
Slide 13: AQST-109: Rapid Absorption With Favorable PK From Part 3 of EPIPHAST
Advancing medicines. Solving problems. Improving lives. AQST-109: Rapid Absorption With Favorable PK Per Initial Data From Part 3 of EPIPHAST Trial 13 • Tmax of 12 minutes at target 4-minute hold time, compared to 50 minutes for 0.3mg Intramuscular Injection (IM) • AUC within clinically relevant per
Slide 14: AQST-109: Rapid Absorption With Comparable PK After Consuming Peanut Butter
Advancing medicines. Solving problems. Improving lives. AQST-109: Rapid Absorption With Comparable PK After Consuming Peanut Butter From Part 3 of EPIPHAST Trial • Study results for the sublingual administration of AQST-109 epinephrine sublingual film after consuming a peanut butter sandwich demonst
Slide 15: AQST-109: De-Risking Potential Administration Errors
Advancing medicines. Solving problems. Improving lives. AQST-109: De-Risking Potential Administration Errors From Part 3 of EPIPHAST Trial Findings • Even if film is swallowed immediately with water, substantial epinephrine absorption and exposure still occurs o Comparable Cmax and overall AUC o Tma
Slide 16: AQST-109: Development Steps
Advancing medicines. Solving problems. Improving lives. 16 AQST-109: Development Steps FDA confirmed that the 505(b)2 approval path is acceptable for AQST-109 Aquestive opened its Investigational New Drug (IND) for AQST-109 after receiving FDA clearance in February 2022 Aquestive received Fast Track
Slide 17: Solving Problems in EPILEPSY
Advancing medicines. Solving problems. Improving lives. Solving Problems in EPILEPSY 17
Slide 18: Solving Problems in Epilepsy: Sympazan and Libervant
Advancing medicines. Solving problems. Improving lives. • Commercialized for Lennox-Gastaut syndrome (LGS), a rare, severe form of epilepsy characterized by multiple manifestations of cognitive impairment and developmental delays1 Solving Problems in EPILEPSY: 18 ≈700K prescriptions annually3 have s
Slide 19: Continued Expansion of Epilepsy Franchise
Advancing medicines. Solving problems. Improving lives. 19 Continued Expansion of Epilepsy Franchise Sympazan Prescriptions by Quarter (2020 – 2022) - 500 1,000 1,500 2,000 2,500 3,000 2020-Q12020-Q22020-Q32020-Q42021-Q12021-Q22021-Q32021-Q42022-Q12022-Q2 TR X B Y Q U AR TE R TRx Count • Sympazan Tr
Slide 20: LIBERVANT: NDA Resubmission Ready to Launch
Advancing medicines. Solving problems. Improving lives. LIBERVANT: NDA Resubmission Ready to LAUNCH • if granted U.S. market access 20 PDUFA Date • December 23, 2021 Ongoing interactions with the FDA “Thank you for your message and your patience as our Office actively works through the orphan-drug e
Slide 21: Seizure Cluster Acute Rescue Market
Advancing medicines. Solving problems. Improving lives. 21 Seizure Cluster Acute Rescue Market References: 1. Symphony Health, Metys®, Jan 2021–Dec 2021. - 50,000 100,000 150,000 200,000 250,000 300,000 350,000 400,000 2018 2019 2020 2021 2022 YTD 2022 EST An nu al T rx b y B ra nd Year ANNUAL TRX B
Slide 22: Financial Summary
Advancing medicines. Solving problems. Improving lives. Financial Summary (NASDAQ: AQST) 22 Capital • $8M registered direct offering closed on June 8, 2022 • Available shelf registration, ATM and Common Stock Purchase Agreement Full Year 2022 Guidance (as of August 2, 2022) • Total revenues of appro
Slide 23: 2022 Inflection Points
Advancing medicines. Solving problems. Improving lives. 2022 Inflection Points • Launch of LIBERVANT if approved by the FDA for U.S. market access • Continue to grow SYMPAZAN prescriptions • AQST-109 • Q2: Completed EPIPHAST study; initiated EPIPHAST II trial of repeat dosing comparative study AQST-
Slide 24: Thank You
Advancing medicines. Solving problems. Improving lives. Thank You
Aquestive Therapeutics — Investor Presentation (August 2022) on 6ix