Aquestive Therapeutics (AQST) Q3 2026 earnings summary

Executive summary

• Anaphylm’s NDA resubmission was accepted as a Class 2 response; the FDA PDUFA goal date is March 16, 2027, with U.S. launch preparations continuing, subject to approval.

• International filing plans target Health Canada in Q4 2026 and the EU in Q1 2027.

• Eton received exclusive U.S. Libervant commercialization rights in October; the agreement includes $10 million upfront and contingent milestones and royalties.

Financial highlights

• Q3 2026 revenue was $7.6 million versus $12.8 million year over year, mainly due to lower Suboxone orders; manufacture and supply revenue was $6.7 million versus $11.5 million.

• 9M revenue rose 14% to $35.8 million from $31.5 million, including $5 million of Zevra-related royalty revenue; manufacturing and supply revenue was $27.4 million versus $28.2 million.

• Q3 net loss was $16.5 million, or $0.13 per share, versus $15.4 million, or $0.14 per share; 9M net loss narrowed to $47.4 million from $51.9 million.

• Q3 adjusted EBITDA loss was $12.2 million versus $8.6 million; 9M adjusted EBITDA loss narrowed to $19.2 million from $35.5 million.

• Q3 operating loss was $14.5 million versus $11.5 million; 9M operating loss narrowed to $26.9 million from $42.2 million.

Outlook and guidance

• FY 2026 guidance was maintained at revenue of $46 million-$50 million and non-GAAP adjusted EBITDA loss of $30 million-$35 million.

• Year-end 2026 cash and cash equivalents are expected to exceed $70 million, including Eton’s $10 million October upfront payment and excluding contingent RTW and Oaktree funding.

• Anaphylm launch preparations target Q1 2027, subject to FDA approval; the PDUFA goal date is March 16, 2027.

• Additional AQST-108 clinical work is expected to begin in Q1 2027; Health Canada and EU filings are planned for Q4 2026 and Q1 2027, respectively.