Aquestive Therapeutics — Third Quarter 2026 Earnings Summary

Financial Performance:

• Total revenue decreased 41% year-over-year to $7.6 million in Q3 2026 from $12.8 million in Q3 2025, driven primarily by quarterly fluctuations in Suboxone product orders.
• Manufacture and supply revenue fell to $6.7 million in Q3 2026 from $11.5 million in Q3 2025, attributed to lower Suboxone revenues partially offset by higher Ondif revenues.
• License and royalty revenue declined to $0.8 million in Q3 2026 from $1.0 million in Q3 2025 due to lower estimated royalty revenues.
• Research and development expenses decreased to $4.3 million in Q3 2026 from $4.5 million in Q3 2025, driven by lower share-based compensation partially offset by higher clinical trial costs for Anaphylm.
• Selling, general and administrative expenses decreased to $14.2 million in Q3 2026 from $15.3 million in Q3 2025, resulting from lower legal fees ($1.5 million), commercial spending ($1.4 million), and regulatory expenses ($0.6 million), partially offset by higher personnel costs ($0.9 million) and share-based compensation ($0.4 million).
• Net loss for Q3 2026 was $16.5 million ($0.13 per share), compared to a net loss of $15.4 million ($0.14 per share) in Q3 2025.
• Non-GAAP adjusted EBITDA loss widened to $12.2 million in Q3 2026 from $8.6 million in Q3 2025.
• Cash and cash equivalents were $90.3 million as of September 30, 2026, down from $121.2 million as of December 31, 2025.
• Total liabilities increased to $190.2 million as of September 30, 2026, from $194.1 million as of December 31, 2025; stockholders' deficit was $(70.8) million as of September 30, 2026.
• Debt decreased significantly to $33 million current and $50.8 million long-term as of September 30, 2026, compared to $10.0 million current and $27.5 million long-term as of December 31, 2025.

Guidance and Future Outlook:

• Full-year 2026 financial guidance remains unchanged, with total revenue expected between $46 million and $50 million.
• Non-GAAP adjusted EBITDA loss for 2026 is projected between $30 million and $35 million.
• The Company expects to submit a New Drug Submission to Health Canada in Q4 2026 and plans to file in the European Union in Q1 2027 for Anaphylm.
• Final FDA approval for Libervant for patients twelve years and older is subject to the expiration of orphan drug exclusivity for Valtoco on January 10, 2027, with a PDUFA goal date of March 23, 2027.
• A Type 9 NDA seeking to add patients six to eleven years of age to the Libervant label has a PDUFA goal date of March 29, 2027.

Business Segments and Product Lines:

• Anaphylm (dibutepinephrine) sublingual film NDA resubmission was accepted by the FDA as a Class 2 response with a PDUFA goal date of March 16, 2027.
• Commercial preparations for Anaphylm are on track, including building a field sales organization and refining launch execution strategies.
• AQST-108 (epinephrine) topical gel advanced in atopic dermatitis following a first-in-human study with no serious or topical adverse events; additional clinical work is expected to begin in Q1 2027.
• The Company manufactured approximately 26 million doses in Q3 2026, down from 44 million doses in Q3 2025; year-to-date manufacturing was 107 million doses in 2026 compared to 108 million doses in 2025.
• Manufacturing partners include Indivior (Suboxone), Cosette Pharmaceuticals (Sympazan), Hypera Pharma (Ondif), and Zambon S.p.A. (Emylif).
• In October 2026, Aquestive granted Eton Pharmaceuticals exclusive U.S. commercialization rights to Libervant, receiving a $10 million upfront payment and eligibility for up to $47.5 million in contingent milestones and mid-teens royalties.

Market and Competitive Landscape:

• Anaphylm is positioned as the potential first and only non-invasive, orally delivered epinephrine product for the treatment of type I allergic reactions, including anaphylaxis.
• Atopic dermatitis affects approximately 7%–10% of U.S. adults and 10%–20% of children.
• The Company's supply chain remains largely unaffected by government tariffs currently in effect, though it continues to monitor proposed trade restrictions.

Risks and Challenges:

• FDA approval for Anaphylm is not guaranteed; risks include the possibility of the FDA disagreeing with study results, requesting additional data, or delaying approval.
• Commercial success depends on market acceptance, reimbursement, and the ability to execute a launch strategy if approved.
• Future revenue is contingent on Eton Pharmaceuticals' commercialization efforts and the achievement of regulatory and sales milestones for Libervant.
• Risks include potential delays in international regulatory approvals, competition, pricing pressures, and the Company's cash requirements and liquidity.
• The Company faces risks related to manufacturing capacity sufficiency, intellectual property, and regulatory changes.

Management Commentary and Tone:

• CEO Daniel Barber expressed confidence in the clear path to making Anaphylm available to patients if approved, citing the March 16, 2027 PDUFA date.
• Management emphasized the potential for Anaphylm to address unmet needs for patients at risk of anaphylaxis due to its ease of use and portability.
• The tone indicates a focus on disciplined launch preparation and commercial readiness, including building a sales organization to engage allergists.

Other Key Points:

• The Company granted Eton Pharmaceuticals exclusive U.S. commercialization rights to Libervant under a 20-year supply agreement where Aquestive remains the exclusive manufacturer.
• Libervant has received tentative FDA approval for patients two to five and twelve years of age and older.
• The AdrenaVerse platform comprises approximately 20 epinephrine prodrugs designed to control absorption and conversion rates across various dosage forms.
• The Company will host an investor call on November 4, 2026, at 8:00 a.m. ET.