Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Investor Presentation (January 2021)
19 slides from Aquestive Therapeutics's investor presentation, Jan 8, 2021
Slide 1: Aquestive Therapeutics Corporate Presentation January 2021
January 2021 Aquestive TherapeuticsCorporate Presentation
Slide 2: Forward Looking Statement
Forward Looking Statement 2 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,” “will,” or the negative of those terms, and similar expr
Slide 3: Advancing Medicines to Improve Therapeutics
Advancing Medicines to Improve Therapeutics Proven track record of success in developing, obtaining FDA approval, and manufacturing differentiated therapeutics with PharmFilm® technologies5 FDA approved products, both proprietary and out-licensed Capital, including current cash, and revenue from lic
Slide 4: PharmFilm: Usable Medication for Undertreated Patients
PharmFilm®: Usable Medication for Undertreated Patients 4 VS Can deliver rapid onset of action with entry into systemic circulation Ease of administration Demonstrated bioequivalence, safety and tolerability Non-invasive DiastatRectal Gel EpinephrineInjection Customizable taste masking profile Unifo
Slide 5: Track Record of Success
Track Record of Success Innovative formulation capabilities Novel and transformative products Expertise in oral transmucosal permeationScalable technology for consistent performance Clinical and regulatory success5 FDA approved products, 2 under FDA review, several in developmentMultiple clinical st
Slide 6: Diversified Portfolio and Pipeline
Diversified Portfolio and Pipeline AQST-108 (Epinephrine)(Anaphylaxis)FDA completed safety review of IND; completed dosing in Phase 1 PK trial in Oct. 2020 Pre-Clinical Clinical Filed Marketed Exservan™ Oral Film (Riluzole)(ALS)Zambon EU license / Seeking US licensee LIBERVANT™ (Diazepam) Buccal Fil
Slide 7: Solving problems in Epilepsy: Libervant (diazepam) Buccal Film
15 Solving problems in EPILEPSY: LIBERVANTTM (diazepam) Buccal Film In development for management of selected, refractory, patients with epilepsy, on stable regimens of AEDs, who require intermittent use of diazepam to control bouts of increased seizure activityPotential to become the preferred resc
Slide 8: Historic Rescue Market – Highly Fragmented
Historic Rescue Market – Highly Fragmented2 8
Slide 9: Refractory Epilepsy Rescue Market in 2020
Refractory Epilepsy Rescue Market in 2020 – Introduction of Approved Nasal Products Rescue Market12Labeled rescue market grew by:~15% in TRxs~45% product units*Rectal gel is on track to deliver:~200,000 in TRxsAccounts for ~270,000 units*TRxs down year over year, units relatively flat*Introduction o
Slide 10: Libervant: Contribution to Patient Care
LIBERVANT: Contribution to Patient Care Plan to demonstrate that LIBERVANTTM, as an orally delivered product, meets one or more of criteria outlined by FDA to be considered a major contribution to patient care versus currently approved and device-driven rectal and nasal products8 10 Convenience of t
Slide 11: Libervant Commentary
LIBERVANT Commentary 11 “…what was found in the usability studies9 was that a caregiver had no trouble administering this into the buccal space.…They are at school and at work, but they always have a concern that a seizure could occur…We don’t have an FDA-approved therapy that they can carry with th
Slide 12: Libervant: Received CRL from FDA, Plan to Resubmit 1H21
LIBERVANT: Received CRL from FDA, Plan to Resubmit 1H21 12 In PK Crossover Study 180323, FDA acknowledged overall Cmax geometric mean ratio (GMR) of LibervantTM versus Diastat was comparableFDA cited that two weight groups showed lower Cmax levels when compared to Diastat:51-62 kg (n=6) (12.5 mg Lib
Slide 13: AQST-108: Solving Problems in Anaphylaxis
Difficult administrationPainful intramuscular injectionsInconvenient portability Suboptimal TreatmentEpiPen® ≈$1.5B market with ~3M total prescriptions13 AQST-108: Solving Problems in ANAPHYLAXIS Oral sublingual film formulation of epinephrine for the treatment of allergic reactions (Type 1), includ
Slide 14: AQST-108: Encouraging results from two pilot PK studies
AQST-108: Solving Problems in ANAPHYLAXIS Encouraging results from two pilot pharmacokinetic (PK) studiesClinical dosing as a sublingual filmGenerated median Tmax similar to subcutaneous and intramuscular injectionsGeometric mean Cmax ranges between approximately 200 pg/mL and 400 pg/mL depending on
Slide 15: Continue to Expand in Our Epilepsy Franchise: Sympazan
Continue to Expand in Our Epilepsy Franchise Cont’d 15 SYMPAZAN®: Continued Growth National trend for total prescriptions were down 7% below prior year trends driven by fewer new prescriptionsIn spite of Q2 and Q4 challenges from COVID SYMPAZAN grew ~110% in TRx and ~80% in prescriber base
Slide 16: Financial Summary
Financial Summary* 16 Financial Results and Cash PositionThird quarter 2020 total revenues of $8.3 million Year-over-year 102% growth in SYMPAZAN® revenueThird quarter 2020 net loss of $16.6 million, or $0.49 loss per shareCash and cash equivalent of $17.1 million at 9/30/20 Full Year 2020 Guidance
Slide 17: Our Focus in 2021
Our Focus in 2021 Continue to expand in our epilepsy franchiseFocus on the FDA approval and launch of LIBERVANT™Generate continued growth in SYMPAZAN® prescriptions Continue to strengthen the capital position of the companyEvaluate various paths to capital Advance our novel epinephrine delivery plat
Slide 18: Corporate Information, References
18 CORPORATE INFORMATION , PHARMFILM® TECHNOLOGY, SYMPAZAN®, LIBERVANT™ AND EPINEPHRINE DATAData on fileLIBERVANT™ REFRACTORY SEIZURESLaxer, K. et al, The consequences of Refractory Epilepsy and its treatment; Epilepsy & Behavior; Vol 37, Aug 2014, Pgs 59-70; https://doi.org/10.1016/j.yebeh.2014.05.
Slide 19: Thank You
wl Aquestive Thank You Advancing medicines. Solving problems. Improving lives.
Aquestive Therapeutics — Investor Presentation (January 2021) on 6ix