Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Q2 2024 Earnings Presentation
21 slides from Aquestive Therapeutics's earnings presentation, Aug 6, 2024
Slide 1: Second Quarter 2024 Earnings Supplemental Materials
Advancing medicines. Solving problems. Improving lives. Second Quarter 2024 Earnings Supplemental Materials August 6, 2024 1
Slide 2: Disclaimer: Forward-Looking Statement
2 ® Disclaimer Forward-Looking Statement Certain statements in this press release 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 the nega
Slide 3: Q2 2024 earnings: key messages
3 Q2 2024 earnings: key messages AnaphylmTM (epinephrine) Sublingual Film ● Completed and received positive topline data for temperature/pH and self-administration studies ● Final supportive study, the Oral Allergy Syndrome (OAS) study, is underway and expected to be completed late in the third quar
Slide 4: Positioned for continued success in 2024
4 Positioned for continued success in 2024 ● FDA approval for Libervant ages 2 to 5 years old ● Completed $77.5 million underwritten public offering including overallotment 1 May ● Presented Anaphylm pharmacokinetic (PK) and pharmacodynamic (PD) data at the 2024 Eastern Allergy Meeting April ● Joine
Slide 5: Upcoming milestones
Upcoming milestones 5 AdrenaverseTM LibervantTM Q3 2024 Q4 2024 Q1 2025 Q2 2025 AQST-108 Pre-IND Meeting AQST-108 Phase 2A StudyInvestor Day AnaphlymTM Pre-NDA Meeting with FDA OAS Study Topline Expand Sales Coverage NDA Submission Pediatric Study Expand Market Access
Slide 6: Anaphylm Program Update
Advancing medicines. Solving problems. Improving lives. Anaphylm Program Update 6
Slide 7: Temperature/pH study pharmacokinetic (PK) results
7 Temperature/pH study pharmacokinetic (PK) results1 1. Aquestive Therapeutics data on file. Test Condition Maximum Plasma Concentration (Cmax) (Test Condition/Room Temperature Water) Area under the curve (AUC) 0-60min (Test Condition/Room Temperature Water) Cold water 106% 98% Hot water 104% 107% L
Slide 8: Temperature/pH study pharmacodynamic (PD) results
8 Temperature/pH study pharmacodynamic (PD) results1 Key Takeaways: ● Topline results demonstrate no statistically significant difference in the maximum increase in systolic blood pressure due to temperature/pH conditions ● PD results for this study are in alignment with prior study results Median C
Slide 9: Self-administration study PK results
9 Self-administration study PK results1 Key Takeaways: ● Cmax was not statistically different whether Anaphylm was self-administered or administered by an HCP ● Median time to maximum concentration (Tmax) was 15 minutes for Anaphylm whether self-administered or administered by a healthcare provider
Slide 10: Self-administration study PD results
10 Self-administration study PD results1 Key Takeaways: ● Topline PD results demonstrate no difference in the median increase in systolic blood pressure whether Anaphylm is self-administered or HCP-administered ● PD results for this study are in alignment with prior study results Median Change in Sy
Slide 11: Oral allergy syndrome (OAS) study
Oral allergy syndrome (OAS) study Repeat dosing of Adrenalin (IM) no allergen exposure 11 Single dose, three-period, randomized, fixed sequence, stratified study using oral allergen syndrome (“OAS”) patients (n=24-36) Comparison of PK/PD after allergen exposure to Adrenalin intramuscular(IM) with no
Slide 12: Pediatric study
Pediatric study1 12 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) PK, PD, and treatment- emergent adverse events (TEAEs) Adrenalin (IM) no allergen exposure Anaphylm single dose administr
Slide 13: Libervant Launch Update
Advancing medicines. Solving problems. Improving lives. Libervant Launch Update 13
Slide 14: Libervant prescriptions remain limited while the Company expands distribution and coverage
14 Libervant prescriptions remain limited while the Company expands distribution, payer coverage and sales coverage for patients 2-5 • Prescriptions average 1.5 cartons per prescription • Our sales force is sized to initially cover up to 2,300 HCPs • Full national retail distribution through the top
Slide 15: Payer coverage/market access for Libervant patients aged 2-5
Payer coverage/market access for Libervant patients aged 2-5 Market Access - Payer Coverage ● Key states have added Libervant patients 2-5 to their Medicaid Drug formularies, e.g., NY, MI, FL, PA, NC, SC, GA, IN, and OH ● Commercial PBM negotiations continue ● Health Plans have begun adding coverage
Slide 16: Financial Results
Advancing medicines. Solving problems. Improving lives. Financial Results 16
Slide 17: Cash position significantly improved following equity raise in Q1 2024
Cash position significantly improved following equity raise in Q1 2024 17 24.9 23.9 95.2 89.9 -15 5 25 45 65 85 105 125 Q3 23 Q4 23 Q1 24 Q2 24 U S D ( M ill io n s ) Ending Cash Balance by Quarter
Slide 18: Base business profitability remains a key focus
Base business profitability remains a key focus 18 (4.9) (4.6) (5.1) (0.5) 0.1 1.7 (0.1) (1.4) 5.6 (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 Q2 22 Q3 22 Q4 22 Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q2 24 U S D ( m il li o n s ) Non-GAAP Adjusted EBITDA Excluding Adjusted R&D Expense
Slide 19: Manufacturing operations continue to generate cash flow
Manufacturing operations continue to generate cash flow 19 42,182 47,041 41,097 36,863 33,458 47,953 46,241 45,328 42,516 34,418 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 D O S E S S H IP P E D ( 0 0 0 ’S ) QUARTER Doses Shipped by Quarte
Slide 20: Current full year guidance
Current full year guidance 20 2024 Outlook • Total revenues of approximately $57 to $60 million • Non-GAAP adjusted EBITDA loss of approximately $20 to $23 million
Slide 21: Thank You
Advancing medicines. Solving problems. Improving lives. Thank You 21
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