Aquestive Therapeutics, Inc. · NASDAQ:AQST
Aquestive Therapeutics — Q4 2025 Earnings Presentation
19 slides from Aquestive Therapeutics's earnings presentation, Mar 5, 2026
Slide 1: Fourth Quarter and Full Year 2025 Earnings Supplemental Materials
Fourth Quarter and Full Year 2025 Earnings Supplemental Materials September 2024 March 4, 2026 Advancing medicines. Solving problems. Improving lives.
Slide 2: Disclaimer
Disclaimer 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 negative of those terms, and simil
Slide 3: Q4 and Full Year 2025 Earnings Key Messages
Q4 and Full Year 2025 Earnings Key Messages Anaphylm (dibutepinephrine) sublingual film for severe allergic reactions, including anaphylaxis • Received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) on January 30, 2026 • CRL was focused on packaging and administrat
Slide 4: Human Factors
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Slide 5: The FDA's DMEPA Group Oversees Human Factors Submissions
The FDA’s DMEPA Group Oversees Human Factors Submissions1 Commissioner Center for Drug Evaluation and Research Office of Surveillance and Epidemiology FDA Organizational Office of Medication Error Prevention and Risk Management Chart Division of Medication Error Prevention and Analysis I & II Divisi
Slide 6: Human Factors Validation Testing Is Designed To Identify Potential "use errors"
Human Factors Validation Testing Is Designed To Identify Potential “use errors”1 Human factors validation testing is conducted to demonstrate that the device can be used by the intended users without serious use errors or problems, for the intended uses and under the expected use conditions. The tes
Slide 7: From the Anaphylm CRL, DMEPA Is Concerned About Specific Potential "human use errors"
From the Anaphylm CRL, DMEPA Is Concerned About Specific Potential “human use errors”: 1. Difficulty opening the Anaphylm primary pouch 2. Potential for tearing the film while opening the pouch 3. Misplacement of the film on top of the tongue (instead of sublingually) 4. Premature removal of film 5.
Slide 8: We believe we have a pathway to addressing pouch opening, film tearing and misplacement
We believe we have a pathway to addressing (1) difficulty opening the pouch, (2) potential for tearing the film and (3) misplacement of film • 2-step fold and tear replaced with single-motion tear Previous Pouch Revised Pouch • Tear line re-enforced to reduce potential film tearing NDC xxxxx-XXX-xx
Slide 9: Remaining items covered through language revisions
The remaining items (4) premature removal of film and (5) improvements to instructions for use will be covered through language revisions • Addition of “Do not remove Anaphylm” language • Confirmation via human factors validation study • Availability of practice demonstration strips to allow patient
Slide 10: DMEPA also indicated we should address potential tolerability use issues in resubmission
DMEPA also indicated we should “(a)ddress potential tolerability use issues in your resubmission.” • Tolerability “use issues” in the human factors study were limited to 4 individuals (out of 166) in a low-risk, simulated use setting • 1 of the 4 participants noted, unprompted, that he “d[id] not li
Slide 11: Pharmacokinetics Study
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Slide 12: FDA requested an additional pharmacokinetic (PK) study under several scenarios
Given the potential “use errors”, FDA requested an additional pharmacokinetic (PK) study to understand the potential impact to PK under several scenarios The FDA requested 5 scenarios: 1. Chewing the film (both swallowing and no swallowing) We believe scenarios #1 and #2 are informative and not appr
Slide 13: Expected PK Study Design
Expected PK Study Design Period 1 Study Day 1 Randomized Anaphylm Administration All subjects will be required to receive: • An FDA approved epinephrine injection product • Anaphylm administration by trained study staff Period 2 Study Day 2 Injectable Epi Some subjects will also: Administration • Us
Slide 14: Recently Completed and Upcoming Expected Key Milestones
Recently Completed and Upcoming Expected Key Milestones CRL issued on Ex-U.S. Clinical PK Study Regulatory Filings January 30, 2026 Anaphlym Type A Meeting NDA Human Factors Study with FDA Resubmission Complete Phase 1 AQST – 108 Clinical Study Q1 2026 Q2 2026 Q3 2026 Q4 2026 14
Slide 15: Fourth Quarter 2025 Results
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Slide 16: Expected to Meet Near-term Milestones with Projected Cash Runway into 2027
Expected to Meet Near-term Milestones with Projected Cash Runway into 2027 Ending Cash Balance by Quarter $129.1 $121.2 120 100 USD (Millions) 80 $68.7 $60.5 60 40 20 0 Q1 25 Q2 25 Q3 25 Q4 25 16
Slide 17: Manufacturing Operations Continue to Generate Cash
Manufacturing Operations Continue to Generate Cash Doses Shipped by Quarter 60,000 50,000 47,953 47,250 46,241 45,328 43,838 43,801 DOSES SHIPPED (000’S) 42,516 43,032 40,000 37,204 33,458 34,418 30,000 27,262 20,000 10,000 0 Q1 23 Q2 23 Q3 23 Q4 23 Q1 24 Q2 24 Q3 24 Q4 24 Q1 25 Q2 25 Q3 25 Q4 25 QU
Slide 18: Initial 2026 Guidance as of March 4, 2026
Initial 2026 Guidance as of March 4, 2026 2026 Outlook • Total revenues of approximately $46-50 million • Non-GAAP adjusted EBITDA loss of approximately $35-30 million 18
Slide 19: Thank You
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Aquestive Therapeutics — Q4 2025 Earnings Presentation on 6ix