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Aquestive Therapeutics, Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 3 November 2026: press release. Guidance figures: 2 kept. The quarter’s numbers.

Key takeaways

  • Revenue fell 41% on Suboxone orders: Total revenue was $7.6 million, down from $12.8 million a year earlier. Management attributed the decline mainly to quarter-to-quarter timing of Suboxone product orders. Source
  • Adjusted EBITDA loss rose to $12.2 million: Non-GAAP adjusted EBITDA loss was $12.2 million, compared with $8.6 million a year earlier, per the release's non-GAAP reconciliation. Source
  • Libervant U.S. rights licensed to Eton: Eton holds exclusive U.S. commercialization rights to Libervant. Aquestive remains the exclusive manufacturer and supplier under a 20-year supply agreement and is eligible for mid-teens royalties on net sales. Source
  • Gross margin fell to 52%: Gross margin on total revenue was 52%, against 65% a year earlier. Non-GAAP gross margin was 55%, against 67%, after excluding share-based compensation and depreciation and amortization. Source
  • Anaphylm resubmission accepted, PDUFA set: The FDA accepted the resubmission as complete and classed it as a Class 2 response, with a PDUFA goal date of March 16, 2027. Source
  • Cash fell to $90.3 million: Cash and cash equivalents were $90.3 million at September 30, 2026, down from $98.5 million at June 30, 2026 and $121.2 million at December 31, 2025. Source
  • Revenue guidance kept at $46 to $50M: Full-year 2026 total revenue guidance remained at $46 to $50 million, unchanged from the previous release. Source

“With a PDUFA goal date of March 16, 2027, we believe we have a clear path to making Anaphylm available to patients and caregivers, if approved,”

Daniel Barber, President and Chief Executive Officer of Aquestive

Guidance

AreaPeriodFigureAgainst last quarter
Total revenue Sourcefull-year 2026$46 to $50 millionKept
Non-GAAP adjusted EBITDA loss Sourcefull-year 2026$35 to $30 millionKept

What changed from last quarter

  • Guidance kept: Full-year 2026 financial guidance was kept unchanged, according to management. Source
  • New: The Anaphylm NDA was resubmitted to the FDA on September 16, 2026. Source
  • New: In October 2026 Eton received exclusive U.S. commercialization rights to Libervant, with Aquestive receiving an upfront payment and contingent payments. Source

Third quarter results

  • Revenue fell 41% on Suboxone orders: Total revenue was $7.6 million, down from $12.8 million a year earlier. Management attributed the decline mainly to quarter-to-quarter timing of Suboxone product orders. Source
  • Net loss rose to $16.5 million: Net loss was $16.5 million, or $0.13 per diluted share, against $15.4 million, or $0.14, a year earlier. Management cited lower revenue, partly offset by lower SG&A, manufacture and supply costs, interest expense and higher interest income. Source
  • Adjusted EBITDA loss rose to $12.2 million: Non-GAAP adjusted EBITDA loss was $12.2 million, compared with $8.6 million a year earlier, per the release's non-GAAP reconciliation. Source

Manufacturing and licensee revenue

  • Manufacture and supply revenue fell: Manufacture and supply revenue was $6.7 million against $11.5 million, mainly on lower Suboxone revenue from order timing, partly offset by higher Ondif revenue. License and royalty revenue was $0.8 million against $1.0 million. Source
  • Doses manufactured fell to 26 million: The company manufactured about 26 million doses in the third quarter, against about 44 million a year earlier. Year to date, about 107 million doses were made, compared with about 108 million. Source
  • Libervant U.S. rights licensed to Eton: Eton holds exclusive U.S. commercialization rights to Libervant. Aquestive remains the exclusive manufacturer and supplier under a 20-year supply agreement and is eligible for mid-teens royalties on net sales. Source

“As we work with the FDA to support an efficient review, we continue to advance our commercial preparations, including building our field sales organization to engage allergists following approval.”

Daniel Barber, President and Chief Executive Officer of Aquestive

Costs and margins

  • Gross margin fell to 52%: Gross margin on total revenue was 52%, against 65% a year earlier. Non-GAAP gross margin was 55%, against 67%, after excluding share-based compensation and depreciation and amortization. Source
  • SG&A fell on lower legal fees: Selling, general and administrative expenses were $14.2 million, against $15.3 million. Lower legal fees of about $1.5 million and lower commercial spending of about $1.4 million were partly offset by higher personnel costs. Source
  • Non-GAAP adjusted costs fell: Non-GAAP adjusted costs and expenses were $19.7 million, against $21.4 million a year earlier, after excluding share-based compensation and depreciation and amortization. Source

Anaphylm regulatory and commercial path

  • Anaphylm resubmission accepted, PDUFA set: The FDA accepted the resubmission as complete and classed it as a Class 2 response, with a PDUFA goal date of March 16, 2027. Source
  • Medical Affairs builds awareness: Medical Affairs is driving healthcare professional awareness and works with allergy-focused patient advocacy groups. The commercial team continues to refine launch execution and market access strategies. Source
  • Described as potential first oral rescue option: Management described Anaphylm as potentially the first and only oral rescue medication for severe allergic reactions, including anaphylaxis, if approved. Source

“These efforts are intended to position us to move quickly toward launch following potential FDA approval.”

Daniel Barber, President and Chief Executive Officer of Aquestive

Libervant approval path

  • Libervant final approval timing: Final approval for patients twelve and older depends on Valtoco orphan exclusivity expiring on January 10, 2027, and on final FDA action, with a PDUFA goal date of March 23, 2027. Source
  • Pediatric label expansion submitted: A Type 9 NDA to add patients aged six to eleven years to the label has been submitted, with a PDUFA goal date of March 29, 2027. Source
  • Tentative approval covers younger patients: Libervant has tentative FDA approval for patients two to five and twelve and older, and is not currently available for U.S. market access. Source

AQST-108 and AdrenaVerse platform

  • AQST-108 advanced into atopic dermatitis: The company completed a first-in-human study of AQST-108 with no serious or topical adverse events observed, and the program is advancing in atopic dermatitis. Source
  • Platform holds about 20 prodrugs: The AdrenaVerse platform has about 20 epinephrine prodrugs for controlling absorption and conversion rates. Management continues to analyze its long-term potential across multiple indications. Source
  • Atopic dermatitis prevalence cited: Management cited that atopic dermatitis affects about 7% to 10% of U.S. adults and 10% to 20% of U.S. children, one of the most common chronic inflammatory skin diseases. Source

Cash, debt and stockholders' deficit

  • Cash fell to $90.3 million: Cash and cash equivalents were $90.3 million at September 30, 2026, down from $98.5 million at June 30, 2026 and $121.2 million at December 31, 2025. Source
  • Long-term debt rose to $50.8 million: Long-term debt, net, was $50.8 million at September 30, 2026, against $27.5 million at December 31, 2025. Royalty obligations, net, were $28.7 million. Source
  • Stockholders' deficit and share count: Total stockholders' deficit was $70.8 million at September 30, 2026. Shares outstanding were 125.7 million, against 122.0 million at December 31, 2025. Source

2026 guidance and tariff exposure

  • Revenue guidance kept at $46 to $50M: Full-year 2026 total revenue guidance remained at $46 to $50 million, unchanged from the previous release. Source
  • EBITDA guidance printed as written: Non-GAAP adjusted EBITDA loss guidance was kept, printed in the release as $35 to $30 million, the same as in the previous release. Source
  • Supply chain largely unaffected by tariffs: Management said, as a U.S.-based manufacturer with U.S.-domiciled intellectual property, the supply chain is largely unaffected by tariffs currently in effect. Source

Coming up, as management said on 3 November 2026

  • Health Canada and EU filings planned: Management expects a New Drug Submission to Health Canada in Q4 2026 and an EU filing in Q1 2027. Source
  • Additional AQST-108 clinical work: Management expects additional AQST-108 clinical work to begin in the first quarter of 2027. Source

Figures management reported

FigureReported
Anaphylm PDUFA goal date SourceMarch 16, 2027
Libervant PDUFA goal date, ages 12 and older SourceMarch 23, 2027
Libervant Type 9 NDA PDUFA goal date SourceMarch 29, 2027
Valtoco orphan exclusivity expiry SourceJanuary 10, 2027
Doses manufactured, third quarter 2026 Sourceapproximately 26 million
Doses manufactured, year to date 2026 Sourceapproximately 107 million
R&D expenses, third quarter 2026 Source$4.3 million

Risks management discussed

  • External: Management continues to monitor proposed tariffs and other trade restrictions, without quantifying any effect in the release. Source
  • Regulatory: Libervant's final approval for patients twelve and older depends on Valtoco exclusivity expiry and final FDA action, as management stated. Source
  • Financial: Eton milestone and royalty receipts depend on contingent events and on net sales, as the release describes. Source

Earlier plans management reported on

  • Met: The NDA resubmission guided for the third quarter of 2026 was completed on September 16, 2026.
  • On track: Commercial preparations are described as on track to support a potential U.S. launch if Anaphylm is approved. Source
  • On track: The prior release said applications in Canada by end-2026 and in the EU in Q1 2027 remained on track.

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.