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Aquestive Therapeutics (AQST) investor relations material
Aquestive Therapeutics Q3 2026 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.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.
- Anaphylm is set for launch, targeting unmet needs with strong clinical and commercial readiness.AQST
H.C. Wainwright 28th Annual Global Investment Conference - Anaphylm's rapid, user-friendly delivery and strong clinical profile position it for major market impact.AQST
12th Annual Cantor Fitzgerald Global Healthcare Conference - Q2 2026 revenue up 38% to $13.8M; Anaphylm NDA resubmission and launch prep on track.AQST
Q2 2026 - Resale registration for 230,271 warrant shares tied to Oaktree credit facility, exercisable at $4.18.AQST
Registration filing - FDA progress, global expansion, and all proposals passed with strong shareholder support.AQST
AGM 2026 - Q1 2026 revenue rose 66% to $14.4M, net loss narrowed, and key regulatory milestones advanced.AQST
Q1 2026 - Virtual annual meeting to vote on directors, executive pay, and auditor ratification.AQST
Proxy filing - AQST-108, a topical epinephrine gel for alopecia areata, targets a post-2028 launch.AQST
Investor Day 2024 - Q1 2025 revenue fell 28% as focus shifted to Anaphylm launch and Libervant sales paused.AQST
Q1 2025
Next Aquestive Therapeutics earnings date
Next Aquestive Therapeutics earnings date
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