Aquestive Therapeutics (AQST) Q1 2025 earnings summary

Executive summary

• NDA for Anaphylm, an oral epinephrine film, was submitted in Q1 2025; FDA acceptance is expected in Q2 2025, with a planned U.S. launch in Q1 2026 if approved.

• Pediatric clinical trial for Anaphylm completed with positive results, finalizing the clinical program.

• Strategic focus shifted to Anaphylm launch, reallocating resources from AQST-108 and Libervant; no appeal on Libervant court decision.

• Libervant's U.S. approval for ages 2–5 was vacated and converted to tentative status due to orphan drug exclusivity; U.S. access expected in 2027 or sooner if exclusivity ends.

• Launch team assembled with deep allergy and commercial experience, leveraging prior EpiPen expertise.

Financial highlights

• Q1 2025 total revenue was $8.7M, down 28% from $12.1M in Q1 2024, mainly due to lower manufacturer, supplier, and royalty revenues.

• Net loss widened to $22.9M ($0.24/share) from $12.8M ($0.17/share) year-over-year, driven by higher SG&A and lower revenue.

• Cash and cash equivalents stood at $68.7M as of March 31, 2025, supported by recent equity offerings and an active ATM facility.

• SG&A expenses rose to $19.1M from $10.7M, while R&D expenses decreased to $5.4M from $5.9M.

• Non-GAAP adjusted EBITDA loss was $17.6M, compared to $7.2M in Q1 2024.

Outlook and guidance

• 2025 revenue guidance revised to $44M–$50M, with adjusted EBITDA loss of $47M–$51M, reflecting paused Libervant sales and increased pre-commercial spending for Anaphylm.

• Cash runway is projected through 2025 and into the initial Anaphylm launch phase in 2026.

• No significant Libervant revenue expected for the remainder of 2025.

• Commercialization efforts for Anaphylm ramping up for a potential Q1 2026 launch, with international submissions planned post-FDA acceptance.