Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Q3 2019 Earnings Presentation
17 slides from Aquestive Therapeutics's earnings presentation, Nov 6, 2019
Slide 1: Aquestive Therapeutics Corporate Presentation
Aquestive Therapeutics Corporate Presentation November 2019 Advancing medicines. Solving problems. Improving lives.
Slide 2: Forward Looking Statement
Forward Looking Statement Certain statements in this presentation and associated oral statements made by management may constitute "forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” "anticipate," "plan," "expect," "estima
Slide 3: Corporate Highlights
Corporate Highlights Commercial-stage, specialty pharmaceutical company with comprehensive capabilities to advance medicines from pipeline to market Advancing a late-stage pipeline that features promising treatments for patients and caregivers living with complex conditions, including hard to manage
Slide 4: Robust Portfolio & Pipeline
Robust Portfolio & Pipeline Pre-Clinical Phase 1 Phase 2 Phase 3 Filed Marketed PROPRIETARY GROWTH DRIVERS Sympazan® Oral Film FDA Clobazam Approved (Lennox-Gastaut syndrome) 2018 LibervantTM Buccal Film * Diazepam (Refractory Seizures) NDA FILING NOVEMBER 2019 AQST-108 * Epinephrine (Anaphylaxis, S
Slide 5: PharmFilm Delivers Meaningful Differentiation
PharmFilm Delivers Meaningful Differentiation Diastat rectal gel Clobazam VS Epinephrine Can deliver rapid onset of Demonstrated injection action with entry into bioequivalence, safety systemic circulation and tolerability Ease of administration Non-invasive 5 Property of Aquestive Therapeutics, Inc
Slide 6: Our Medicines
Our Medicines Advancing medicines. Solving problems. Improving lives.
Slide 7: Solving Problems In Epilepsy: LGS
Solving Problems In EPILEPSY Lennox-Gastaut Syndrome (LGS) : A rare, severe, and intractable form of epilepsy involving daily seizures of multiple types that often result in severe cognitive impairment and developmental delays1 50K Of nearly 3.4M patients 30 40% to LGS with epilepsy, of people with
Slide 8: Sympazan Overview and Launch Update
Sympazan Overview and Launch Update Sympazan (clobazam) oral film Launch Update o Approved in November 2018 and launched in o Shipments from wholesalers to retailers grown December 2018 by over 50% since end of 2Q19 o First and only film approved for treatment of o Prescriber base increased by over
Slide 9: Solving Problems In Epilepsy
Solving Problems In EPILEPSY Refractory seizures: The failure of 2 or more AED regimens to achieve sustained freedom of seizures resulting in comorbid illnesses, psychological dysfunction, social stigma, and increased risk of mortality1-3 1M 1.2M Epilepsy epilepsy patient visits 4 patients5 suffer f
Slide 10: Libervant (diazapem) Buccal Film Overview
Libervant™ (diazapem) Buccal Film Overview Overview o In development for management of select patients with refractory epilepsy who require treatment to control episodes of increased seizure activity, or “seizure clusters” o Potential to become the preferred rescue medication by patients and provide
Slide 11: Pivotal Trial Design and Expected Timing
Pivotal Trial Design and Expected Timing 2017 2018 2019 2020 NDA PDUFA Filed EMU Study EMU Starts Interim Topline Data Analysis Data Crossover Study Launch Study Patient Group Primary Objectives Secondary Objectives Dose Proportionality Healthy adults • Demonstrate dose proportional plasma levels fo
Slide 12: Libervant Crossover Study
Libervant™ Crossover Study Trial Design Met Co-Primary Endpoints Based on Preliminary Analysis • Single dose crossover study • Diazepam exposure following buccal film showed • Compare diazepam plasma concentrations comparable bioavailability to rectal gel as assessed from a dose of Libervant and its
Slide 13: Solving Problems In Anaphylaxis
Solving Problems In ANAPHYLAXIS A systemic hypersensitivity reaction that can be rapidly and unpredictably fatal (drug, food, insect venom)1 Affects up to Increases Approximately 5% U.S. Emergency of population 2 Department 186 225 to and hospital visits deaths per year3 Suboptimal Treatment EpiPen®
Slide 14: AQST-108 Proof of Concept Study in Canada
AQST-108 Proof of Concept Study in Canada AQST-108 Overview • Sublingual film formulation of epinephrine for the treatment of anaphylaxis and severe allergic reactions o Re-formulated and more advanced prototype developed after first human proof concept trials • Phase 1 dose escalation proof-of-conc
Slide 15: Financials, Team & Upcoming Milestones
Financials, Team & Upcoming Milestones Advancing medicines. Solving problems. Improving lives.
Slide 16: Financial Summary
Financial Summary Third Quarter 2019 Results Full Year 2019 Guidance • Total revenues of $12.4 million • Total revenues of $45 to $47 million • Manufacturing revenue of $9.2 million • Non-GAAP gross margins of 67% to 69% with 72 million shipped product doses • Non-GAAP EBITDA loss of $49 to $50 • Ad
Slide 17: Multiple Upcoming Near-Term Catalysts
Multiple Upcoming Near-Term Catalysts = Milestone Achieved Sympazan NDA Filed FDA Launch and Epilepsy (clobazam) Approval Market Activation Rolling NDA Libervant EMU Adult Submission PDUFA Launch (diazepam) Data Date Crossover Study AQST-108 Phase 1 File (epinephrine) Data IND Exservan NDA PDUFA (ri
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