Aquestive Therapeutics (AQST) Q4 2025 earnings summary

Executive summary

• Anaphylm NDA resubmission is targeted for Q3 2026 after addressing FDA's human factors and PK study requirements, following a Complete Response Letter focused on packaging and administration issues.

• Expanded clinical and commercial teams, including key hires and doubling medical affairs staff, with strengthened leadership and infrastructure.

• Settlement of a nine-year defamation lawsuit and continued focus on simplifying litigation workload, including a legal settlement with Neurelis.

• Strategic prioritization of Anaphylm launch over Libervant, with ongoing licensing discussions for Libervant and ex-US Anaphylm, and regulatory applications planned for Canada and EU.

• AQST-108 topical gel advanced to a second Phase 1 trial for alopecia areata, with data expected in Q2 2026.

Financial highlights

• Q4 2025 revenue rose 10% year-over-year to $13M, driven by manufacturing and supply revenue increases.

• Full-year 2025 revenue was $44.5M, down from $57.6M in 2024 due to prior year one-time deferred revenue recognition.

• R&D expenses decreased to $3.2M in Q4 2025 and $17.2M for the year, reflecting lower clinical trial costs.

• SG&A expenses, including one-time legal costs, rose to $32.8M in Q4 and $79.8M for 2025, mainly due to legal and commercial spending.

• Net loss for 2025 was $83.8M ($0.78/share) including one-time legal expenses; adjusted EBITDA loss was $49.7M.

• Ended 2025 with $121.2M in cash and equivalents, supporting ongoing development and regulatory activities.

Outlook and guidance

• 2026 revenue guidance: $46M–$50M; non-GAAP adjusted EBITDA loss: $30M–$35M.

• Expect to end 2026 with ~$70M in cash, excluding additional RTW proceeds or out-licensing.

• Guidance includes costs for Anaphylm NDA resubmission, pre-commercial spending, AQST-108 clinical trials, and regulatory filings in Canada/EU.