Aquestive Therapeutics, Inc.
Key statistics
from XBRL data in SEC filingsAI briefing
from the latest 10-K, 10-Q and 8-K eventsAquestive Therapeutics is a specialty pharmaceutical company that manufactures licensed oral film products and is developing Anaphylm, an epinephrine sublingual film, as a non-invasive treatment for type I allergic reactions including anaphylaxis.
What they do
Aquestive operates two cGMP manufacturing and packaging facilities in Portage, Indiana, registered with the DEA for Schedule II-V, where it produces its licensed products Suboxone, Emylif, Ondif and Sympazan. The company has produced over 2.5 billion doses since inception and also develops proprietary product candidates using its oral film and epinephrine prodrug delivery technologies. It relies on third-party CROs for clinical trial conduct and purchases raw materials including APIs from qualified vendors, with packaging foil supplied by a single manufacturer.
Revenue drivers
- Licensed products (Suboxone, Emylif, Ondif, Sympazan) — Manufactured at the Indiana facilities and sold under license agreements; these currently generate essentially all of the company's reported revenue.
- Anaphylm (dibutepinephrine) sublingual film — Late-stage product candidate for type I allergic reactions including anaphylaxis; pre-approval, no revenue today, with an NDA resubmission guided to Q3 2026.
- AdrenaVerse pipeline / AQST-108 — Early-stage epinephrine prodrug platform including AQST-108 topical gel being explored for alopecia areata and atopic dermatitis; no revenue and development continues toward 2027.
Recent performance
Second quarter 2026 revenue was $13.8M, down slightly from $14.4M in Q1 2026 and roughly flat versus $13.0M in Q4 2025. Full-year 2025 revenue was $44.5M, down from $57.6M in 2024, and 2025 net loss widened to $83.8M from $44.1M. Operating cash flow was negative $52.4M in 2025, and at June 30, 2026 the company reported $98.5M of cash, $188.7M of total liabilities and negative shareholder equity of $56.6M. In Q2 2026 the company completed the human factors validation study and pharmacokinetic study intended to address the January 30, 2026 Anaphylm CRL, reporting improvement on each CRL deficiency and no serious adverse events in the PK study.
Strategy
The near-term priority is resubmitting the Anaphylm NDA to the FDA in Q3 2026 with a request for expedited review, following completion of the human factors and PK studies addressing the CRL. The company is preparing a focused, allergist-first U.S. launch if approved and plans ex-U.S. filings, starting with Canada by the end of 2026 and the EU in Q1 2027, with the UK and other markets expected in 2027. It continues pre-launch medical affairs and payer engagement, and expanded its Scientific Advisory Board. It also continues manufacturing its licensed products and advancing the AdrenaVerse platform, including AQST-108, into 2027. Management has flagged that a potential Anaphylm approval would substantially increase indebtedness, and quarterly principal amortization on the 13.5% Notes begins in June 2026.
Risks
- Anaphylm regulatory risk — The FDA issued a Complete Response Letter for Anaphylm on January 30, 2026, and there is no assurance the resubmission will be accepted, reviewed on an expedited basis, or approved.
- Liquidity and going-concern pressure — The company had negative shareholder equity of $56.6M and total liabilities of $188.7M at June 30, 2026, with 2025 operating cash outflow of $52.4M and quarterly principal amortization on the 13.5% Notes starting June 2026.
- Dependence on licensed products — Suboxone, Emylif, Ondif and Sympazan account for essentially all current revenue, and 2025 revenue declined to $44.5M from $57.6M in 2024.
- Competition and generic clobazam — The business competes with multinational, specialty and generic drug companies, and Sympazan faces generic clobazam tablet and suspension alternatives, while Anaphylm would compete against existing epinephrine autoinjectors.
Outlook
Management reaffirmed guidance to resubmit the Anaphylm NDA in Q3 2026 and to begin ex-U.S. filings in Q4 2026, with Canada targeted by end-2026 and the EU in Q1 2027. The company is preparing commercial readiness for a potential Anaphylm launch and continues to advance AQST-108 and the AdrenaVerse platform toward 2027. No revenue guidance or profitability timeline was provided in the excerpts, and management noted that a potential approval would substantially increase indebtedness.