Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Q1 2024 Earnings Presentation
16 slides from Aquestive Therapeutics's earnings presentation, May 8, 2024
Slide 1: First Quarter 2024 Earnings Supplemental Materials
Advancing medicines. Solving problems. Improving lives. Advancing medicines. Solving problems. Improving lives. First Quarter 2024 Earnings Supplemental Materials May 7, 2024 1
Slide 2: Disclaimer
Advancing medicines. Solving problems. Improving lives. 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
Slide 3: Q1 2024 Earnings: Key Messages
Advancing medicines. Solving problems. Improving lives. 3 Q1 2024 Earnings: Key Messages AnaphylmTM (epinephrine) Sublingual Film ❖ Pivotal study met all primary and secondary endpoints ❖ Successful completion of a Type C meeting with the FDA ❖ On track for goal of submitting a New Drug Application
Slide 4: Positioned for continued success in 2024
Advancing medicines. Solving problems. Improving lives. 4 Positioned for continued success in 2024 ❖ Completion of a positive Type C meeting with the FDA February ❖ Presented Anaphylm pharmacokinetic (PK) and pharmacodynamic (PD) data at the 2024 AAAAI Annual Meeting ❖ Initiated AQST-108 FIH study J
Slide 5: Anaphylm Program Update
Advancing medicines. Solving problems. Improving lives. Anaphylm Program Update 5
Slide 6: Projected Clinical Timeline
Q1 2024 Q2 2024 Q3 2024 Q4 2024 Temperature/pH study Self administration study Allergen exposure study Pediatric study File NDAPre-NDA Meeting 6 Advancing medicines. Solving problems. Improving lives. Pivotal Study Completed FDA Type C Meeting Completed Projected Clinical Timeline
Slide 7: Temperature/pH Study
Advancing medicines. Solving problems. Improving lives. Temperature/pH Study Hot water (50° C) Lemon water (target pH 3) Cold water (2° C) 7 Room temperature water1 (25° C) Sodium bicarbonate water (target pH 8) Study Design 1 Room temperature water used as reference. Single dose, five-period, cross
Slide 8: Self-Administration Study
Advancing medicines. Solving problems. Improving lives. Self-Administration Study Healthy Volunteers N=30 Adrenalin (IM) healthcare provider administration 8 Study Design Single dose, three-period, cross-over design using healthy adult volunteers (n=36) Endpoints Comparison of PK/PD between self-adm
Slide 9: Allergen Exposure Study
Advancing medicines. Solving problems. Improving lives. Allergen Exposure Study Healthy Volunteers N=30 (n=24) Adrenalin (IM) no allergen exposure 9 Study Design Single dose, two-period, partially randomized cross-over design using oral allergen syndrome (“OAS”) patients (n=36) Endpoints Comparison
Slide 10: Pediatric Study
Advancing medicines. Solving problems. Improving lives. Pediatric Study Healthy Volunteers N=30 10 Study Design Single dose, single treatment, multi-center, parallel design study in pediatric pati nts ages 7-17 (weight ≥ 30kg) at heightened risk of anaphylaxis (n=36) Endpoints PK, PD, and treatment-
Slide 11: Financial Results
Advancing medicines. Solving problems. Improving lives. Financial Results 11
Slide 12: Cash position significantly improved following Q1 equity raise
Advancing medicines. Solving problems. Improving lives. Cash position significantly improved following Q1 equity raise 12 22.4 24.9 23.9 95.2 -15 5 25 45 65 85 105 125 Q2 23 Q3 23 Q4 23 Q1 24 U S D ( m ill io n s ) Ending cash balance by quarter
Slide 13: Base business profitability remains a key focus
Advancing medicines. Solving problems. Improving lives. Base business profitability remains a key focus 13 (3.5) (4.9) (4.6) (5.1) (0.5) 0.1 1.7 (0.1) (1.4) (6.0) (5.0) (4.0) (3.0) (2.0) (1.0) 0.0 1.0 2.0 3.0 Q1 22 Q2 22 Q3 22 Q4 22 Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 U S D ( m il li o n s ) Non-GAAP adju
Slide 14: Manufacturing operations continue to generate cash flow
Advancing medicines. Solving problems. Improving lives. Manufacturing operations continue to generate cash flow 14 42,182 47,041 41,097 36,863 33,458 47,953 46,241 45,328 42,516 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 D O S E S S H IP P E D (
Slide 15: Current full year guidance: 2024 Outlook
Advancing medicines. Solving problems. Improving lives. Current full year guidance 2024 Outlook • Total revenues of approximately $48 to $51 million • Non-GAAP adjusted EBITDA loss of approximately $22 to $26 million 15
Slide 16: Thank You
Advancing medicines. Solving problems. Improving lives. Thank You
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