Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Q3 2024 Earnings Presentation
20 slides from Aquestive Therapeutics's earnings presentation, Nov 4, 2024
Slide 1: Third Quarter 2024 Earnings Supplemental Materials
Advancing medicines. Solving problems. Improving lives. September 2024 Advancing medicines. Solving problems. Improving lives. Advancing medicines. Solving problems. Improving lives. 1 Third Quarter 2024 Earnings Supplemental Materials November 4, 2024
Slide 2: Disclaimer
© 2024 Aquestive Therapeutics, Inc. 2 ® Disclaimer Certain statements in this presentation include “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
Slide 3: Q3 2024 earnings key messages
3 Q3 2024 earnings key messages • Anaphylm (epinephrine) Sublingual Film • Positive topline results - Oral Allergy Syndrome challenge study (referred to as OASIS) • Pre-NDA meeting scheduled for Q4 2024 • Anticipate commencement of the single-dose pediatric study immediately following the pre-NDA me
Slide 4: Positioned for a strong finish in 2024
4 Positioned for a strong finish in 2024 ● Announced positive topline data from Anaphylm self- administration study ● Began enrollment of the OASIS study August ● Continued to expand market access for Libervant ages 2-5 for both commercial and CMS patients July ● Submitted request for pre- NDA meeti
Slide 5: Milestones
5 Milestones AQST – 108 Libervant® (ages 2-5) Q3 2024 Q4 2024 Q1 2025 Q2 2025 AQST-108 Pre-IND Meeting AQST-108 Phase 2a Study Initiation Investor Day – held on September 27 AnaphlymTM Pre-NDA Meeting with FDA OAS Study Topline - Completed Expand Sales Coverage NDA Submission Pediatric Study Expand
Slide 6: Anaphylm Program Update
<< Aquestive’ Anaphyim™ Program Update
Slide 7: Anaphylm program update and next steps
7 Anaphylm program update and next steps • Completed OASIS study • Full topline clinical data released and available on the Aquestive website (https://investors.aquestive.com/events-and-presentations) • Additional analysis provided on subjects with edema or oral swelling • All planned adult studies
Slide 8: OASIS study – symptomatic oral edema has no impact on Anaphylm's PK performance
8 OASIS study – symptomatic oral edema has no impact on Anaphylm’s pharmacokinetics (PK) performance¹ Anaphylm administered with and without allergen challenge: • Remains above the Adrenalin manual intramuscular (Manual IM) out to 45 minutes • Has similar PK profiles • Demonstrates consistent median
Slide 9: Planned pediatric study
9 Planned pediatric study1 Single dose, single treatment, multi-center, parallel design study in pediatric patients ages 7-17 (weight ≥ 30kg) at heightened risk of anaphylaxis (n=18-24) Pharmacokinetics (PK), pharmacodynamics (PD), and treatment-emergent adverse events (TEAEs) Adrenalin (IM) no alle
Slide 10: AQST-108 Program Update
<< Aquestive’ AQST-108 Program Update
Slide 11: AQST-108 planned Phase 2a clinical study for alopecia areata
11 AQST-108 planned Phase 2a clinical study for alopecia areata¹ 1. Plan on commencing study after alignment with the FDA. Phase 2a Study Design • 24-48 subjects, 4 doses • 12 – 24 weeks² • Change from baseline ≥10% in Severity of Alopecia Tool (SALT) score at Week 12 • Trichoscopy evaluations and l
Slide 12: Libervant Launch Update
<< Aquestive’ Libervant® Launch Update
Slide 13: Libervant prescriptions for ages two to five are increasing
13 Libervant prescriptions for patients two to five years of age are increasing as patient access and sales force expands • Libervant launch continues to expand and remains on target • Prescriptions average 1.8 cartons per prescription¹ • Sales force active and sized to cover 2,300 healthcare prescr
Slide 14: Payer coverage and market access continues to expand
14 Payer coverage and market access continues to expand ● Medicaid reimbursable in all states with clinically appropriate edits (e.g., age) ● Negotiations continue with commercial pharmacy benefit manager companies (PBMs – agreements completed with 2 of the top 3 PBMs for Libervant patients 2-5 ● Co
Slide 15: Financial Results
<< Aquestive’ Financial Results
Slide 16: Cash position significantly improved following equity raise in Q1 2024
16 Cash position significantly improved following equity raise in Q1 2024 23.9 95.2 89.9 77.9 0 20 40 60 80 100 120 Q4 23 Q1 24 Q2 24 Q3 24 U S D ( M ill io n s ) Ending Cash Balance by Quarter
Slide 17: EBITDA excluding research and development expenses
17 EBITDA excluding research and development expenses¹ (4.6) (5.1) (0.5) 0.1 1.7 (0.1) (1.4) 5.6 -1.6 (6.0) (5.0) (4.0) (3.0) (2.0) (1.0) 0.0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 Q3 22 Q4 22 Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q2 24 Q3 24 U S D ( m il li o n s ) Non-GAAP Adjusted EBITDA Excluding Adjusted R&D Expe
Slide 18: Doses Shipped by Quarter
18 42,182 47,041 41,097 36,863 33,458 47,953 46,241 45,328 42,516 34,418 43,818 0 10,000 20,000 30,000 40,000 50,000 60,000 Q1 22 Q2 22 Q3 22 Q4 22 Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q2 24 Q3 24 D O S E S S H IP P E D ( 0 0 0 ’S ) QUARTER Doses Shipped by Quarter Manufacturing operations continue to gene
Slide 19: Current full year guidance 2024 Outlook
19 Current full year guidance 2024 Outlook • Total revenues of approximately $57 to $60 million • Non-GAAP adjusted EBITDA loss of approximately $20 to $23 million
Slide 20: Thank You
<< Aquestive’ Thank You
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