Aquestive Therapeutics (AQST) Q1 2026 earnings summary

Executive summary

• Q1 2026 featured significant progress for Anaphylm and AQST-108, including completion of key studies, a Type A FDA meeting, and advancing global regulatory strategies for Anaphylm in the U.S., Canada, EU, and UK.

• Expanded Medical Affairs team and sales force to increase awareness and engagement with healthcare providers and advocacy groups, with commercial launch preparations for Anaphylm underway.

• Strengthened financial position with $110.7 million in cash at quarter-end and a new $150 million debt facility, improving liquidity and extending the cash runway.

• Net loss narrowed to $8.1 million ($0.07 per share) from $22.9 million ($0.24 per share) year-over-year, reflecting improved operating performance and lower expenses.

• AQST-108 completed Phase I safety study with no drug-related adverse events and identified a biomarker signal for further dermatology studies.

Financial highlights

• Total revenues rose 66% year-over-year to $14.4 million in Q1 2026, driven by higher license, royalty, and manufacturing revenues.

• License and royalty revenue increased to $5.4 million, mainly from Zevra, while manufacturing and supply revenue reached $8.8 million, led by Suboxone.

• Research and development expenses decreased to $4.2 million, and SG&A expenses dropped to $11 million, reflecting lower legal and one-time costs.

• Non-GAAP adjusted EBITDA loss improved to $1.7 million from $17.6 million year-over-year.

• Gross margin on total revenue improved to 76%–77% from 58%–61% year-over-year.

Outlook and guidance

• Guidance maintained for Q3 2026 Anaphylm NDA resubmission, with a six-month FDA review anticipated and efforts to expedite.

• 2026 revenue expected at $46–$50 million and non-GAAP adjusted EBITDA loss of $35–$30 million.

• Projected cash runway extends into 2027, supporting near-term milestones and Anaphylm launch if approved.

• No update to full-year guidance until further regulatory milestones are achieved.