Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Corporate Update (December 2018)
31 slides from Aquestive Therapeutics's corporate update, Dec 11, 2018
Slide 1: Corporate Update December 2018
Corporate UpdateDecember 2018
Slide 2: Forward Looking Statements
2 Forward Looking Statements Certain statements in this presentation and associated oral statements made by management may constitute "forward-looking statements.” Words such as “believes”, “expects”, “projects”, “future” and similar expressions often identify such forward-looking statements. These
Slide 3: Corporate Highlights
Corporate Highlights 3 Broad, Late-Stage Product Pipeline Two late-stage CNS product candidates aimed at improving treatment paradigmsComplex molecule product candidates in immunology and endocrinology targeting large market opportunities Commercial-Stage, Innovative Technology & Global IP Received
Slide 4: Strategic Evolution
4 Strategic Evolution Unlocking value by advancing proprietary CNS and complex molecules Emerging Leader in Epilepsy & CNSDiazepam,Clobazam, Riluzole Pioneer in Deliveryof Complex MoleculesEpinephrine, Octreotide Marketed ProductsSuboxone, Zuplenz Commercialization Team Build Innovative Product Deve
Slide 5: Proprietary and Partnered Pipeline Summary
Proprietary and Partnered Pipeline Summary 5
Slide 6: Pipeline Milestones and Upcoming Near-Term Catalysts
AQST-305(octreotide) Human PoC Data APL-130277(apomorphine) NDA Filed PDUFA Date Launch(1) AQST-108(epinephrine) IND Phase 1 Data Exservan(riluzole) PDUFA Date Launch KP415(2)(d-methylphenidate) Positive Top-Line Safety and Efficacy Data Multiple Upcoming Near-Term Catalysts Aquestive estimateAquest
Slide 7: Experienced Management Team & Board of Directors
Experienced Management Team & Board of Directors 7 Keith Kendall President, Chief Executive Officer & Director Mark SchobelChief Innovation & Technology Officer John MaxwellSVP, Chief Financial Officer Theresa WoodSVP, Human Resources and Organizational Development Peter BoydSVP, Operations and Valu
Slide 8: PharmFilm Technology
8 PharmFilm Technology First FDA approved oral films for lingual, sublingual and combination drug deliveryMultiple advantages versus IV, tablet and liquid formulationsWorld leader in supplying oral films for prescription pharmaceutical products FDA- and DEA-inspected facilities with capacity suffici
Slide 9: CNS Product Portfolio & Strategy
CNS Product Portfolio & Strategy
Slide 10: Sympazan (clobazam oral film) Launch underway
Sympazan(clobazam oral film)Launch underway
Slide 11: Sympazan: Positioning in LGS Treatment Paradigm
11 Sympazan: Positioning in LGS Treatment Paradigm Patients with Epilepsy 3.4M Patients with Refractory Seizures 1.2M LGS Patients (55K) Atypical LGS Crushed Tablet or Solution Administered via G-tube Solutions Tablets Crushed Tablet, Mixed with Food or Dissolved Ability to Swallow Compliance Low Mo
Slide 12: Commercialization Strategy
Commercialization Strategy Commercial leadership with multiple product starts, including launches of Diastat and ONFI30 person sales team, led by three seasoned Regional Directors, designed to support high prescribing HCPs in epilepsy space Completed home study and live training at National Sales Me
Slide 13: Libervant (diazepam buccal film)
Libervant(diazepam buccal film)
Slide 14: Libervant: Untreated Patient Growth Opportunity
14 Libervant: Untreated Patient Growth Opportunity Epileptic seizures affect ~3.4 million patients in US200K+ new diagnoses per yearOnly ~250K doses of diazepam rectal gel prescribed annually, due to:18-step administration process increases caregiver burdenPatient dignity and respectInaccurate dosin
Slide 15: Libervant: Proprietary Formulation with Potential to Expand Patient Usage
15 Libervant: Proprietary Formulation with Potential to Expand Patient Usage Buccal film administration of diazepamDissolves quickly and demonstrates rapid achievement of therapeutic blood levelsIn development as rescue therapy for breakthrough epileptic seizuresAlternative to Diastat® (diazepam rec
Slide 16: Libervant: Pivotal Trial Design and Expected Timing
Libervant: Pivotal Trial Design and Expected Timing 16 Additional clinical trials include a food effect, phase one study and a label comprehension study Study Patient Group Primary Objectives Secondary Objectives Dose Proportionality Study (#162013) Healthy adults Demonstrate dose proportional plasm
Slide 17: Libervant: Healthy Volunteer Pivotal PK Data
17 Libervant: Healthy Volunteer Pivotal PK Data Libervant produces peak diazepam plasma levels similar to diazepam rectal gel using lower doses of active ingredientPlot (right) shows 15 mg Libervant vs 20 mg DiastatLess inter-subject variability compared to all doses of Diastat Fasted conditions; N=
Slide 18: Libervant: No 'Non-Responders'
18 Libervant: No ‘Non-Responders’ Current standard of care (Diastat rectal gel):Exhibits a population subset that does not obtain expected plasma concentrations of diazepamLibervant: Consistent plasma concentrations Even Diastat ‘non-responders’ received acceptable plasma concentrations with Liberva
Slide 19: Libervant: Study Completed, Strong Results
Libervant: Study Completed, Strong Results 19 Based on comparison of 21 subjects with valid pharmacokinetic profiles for both Treatment A and Treatment B
Slide 20: Libervant: Adult EMU Safety & Tolerability
Libervant: Adult EMU Safety & Tolerability 20 Majority of the treatment-emergent adverse events (TEAE) in this study were classified as unrelated to study drugThe most common adverse events that were classified as probably related to study drug were somnolence and dizziness and were relatively infre
Slide 21: Exservan (riluzole oral film)
Exservan(riluzole oral film)
Slide 22: Exservan (Riluzole)
22 Exservan (Riluzole) Oral soluble film formulation of riluzole for the treatment of Amyotrophic Lateral Sclerosis (ALS)Potential to be the only formulation of riluzole that doesn’t require water or liquid for swallowingCompleted a pilot PK and pivotal PK study, as well as a food effect studyAll st
Slide 23: Complex Molecule Candidates & Partnered Products
Complex Molecule Candidates & Partnered Products
Slide 24: AQST-108 (epinephrine): Injection to Oral
24 AQST-108 (epinephrine): Injection to Oral 2017 injectable epinephrine market estimated to be approximately $1.7B and over 3.5M total prescriptionsPotential alternative to EpiPen® intramuscular injection, the market leader in anaphylaxis treatmentAQST-108 has the potential to:Reduce treatment burd
Slide 25: AQST-108 (epinephrine): Proof of Concept Study
25 AQST-108 (epinephrine): Proof of Concept Study Successfully demonstrated ability to achieve significant oral absorption using PharmFilm technologyHighlighted the variability inherent in EpiPen administration Mean profiles for Epinephrine Sublingual Film (ESF) compared to EpiPen® in Human Crossove
Slide 26: AQST-108 (epinephrine): Optimized Formulation Appears Successful in Pig Model
26 AQST-108 (epinephrine): Optimized Formulation Appears Successful in Pig Model
Slide 27: AQST-305 (octreotide): Gateway to Peptides and Biologics via Sublingual Film
27 AQST-305 (octreotide): Gateway to Peptides and Biologics via Sublingual Film Alternative to Sandostatin LAR®, a monthly depot injectionMarket leader in treatment of acromegaly and neuroendocrine tumors$843 million in sales in 2017(1)Twice daily administration of sublingual film eliminates need fo
Slide 28: Validated Commercial Success of PharmFilm
28 Validated Commercial Success of PharmFilm Reduces potential for abuse and improves safety, compliance, dissolution, taste and textureMarket leader for treatment of opioid addiction that affects more than two million people in the United StatesOver one billion doses delivered to patientsCaptured ~
Slide 29: Apomorphine (APL-130277): Late-Stage Partnership with Sunovion
29 Apomorphine (APL-130277): Late-Stage Partnership with Sunovion Sunovion developed a sublingual film formulation of apomorphine utilizing Aquestive’s PharmFilm technology Currently delivered via injection (Apokyn Pen)Aims to fulfill unmet need in patients with dysphagiaNDA under review for the tre
Slide 30: Multiple Upcoming Near-Term Catalysts
AQST-305(octreotide) Human PoC Data APL-130277(apomorphine) NDA Filed PDUFA Date Launch(1) AQST-108(epinephrine) IND Phase 1 Data Exservan(riluzole) PDUFA Date Launch KP415(2)(d-methylphenidate) Positive Top-Line Safety and Efficacy Data Multiple Upcoming Near-Term Catalysts Aquestive estimateAquest
Slide 31: Aquestive
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