Aquestive Therapeutic | 8-K: FY2026 Q1 Revenue Beats Estimate at USD 14.45 M

Revenue: As of FY2026 Q1, the actual value is USD 14.45 M, beating the estimate of USD 10.9 M.

EPS: As of FY2026 Q1, the actual value is USD -0.07, beating the estimate of USD -0.1371.

EBIT: As of FY2026 Q1, the actual value is USD -351 K.

Revenue

Total revenues: Aquestive Therapeutics, Inc.’s total revenues increased by 66% to $14.4 million in the first quarter of 2026, up from $8.7 million in the first quarter of 2025.
License and royalty revenue: This segment saw an increase to $5.4 million in Q1 2026 from $0.8 million in Q1 2025, primarily driven by royalty revenue from Zevra.
Manufacture and supply revenue: This revenue stream increased to $8.8 million in Q1 2026 from $7.2 million in Q1 2025, mainly due to higher Suboxone revenues, partially offset by lower Ondif revenues.

Operating Expenses

Manufacture and Supply Expenses (GAAP): These expenses were $3,469 thousand in Q1 2026, compared to $3,652 thousand in Q1 2025.
Research and development expenses: These expenses decreased to $4.2 million in Q1 2026 from $5.4 million in Q1 2025, primarily due to reduced clinical trial costs for the Anaphylm development program, despite increased R&D personnel costs.
Selling, general and administrative expenses: These expenses decreased to $11.0 million in Q1 2026 from $19.1 million in Q1 2025, driven by a one-time Anaphylm PDUFA fee in the prior year, lower legal fees, reduced commercial spending, and lower regulatory and licensing fees, partially offset by higher severance, personnel, and share-based compensation costs.

Profitability

Net loss: The net loss for Q1 2026 was - $8.1 million, a significant improvement from the - $22.9 million net loss in Q1 2025, mainly due to decreased operating expenses and increased revenues.
Non-GAAP adjusted EBITDA loss: This loss was - $1.7 million in Q1 2026, compared to - $17.6 million in Q1 2025.
Gross Margin on total revenue (GAAP): The GAAP gross margin was 76% in Q1 2026, up from 58% in Q1 2025.
Non-GAAP Gross Margin on total revenue: The non-GAAP gross margin was 77% in Q1 2026, compared to 61% in Q1 2025.

Cash and Liquidity

Cash and cash equivalents: Aquestive Therapeutics, Inc. reported $110.7 million in cash and cash equivalents as of March 31, 2026.
Debt Refinancing: Aquestive Therapeutics, Inc. entered into a new five-year term loan facility of up to $150.0 million on May 12, 2026, with Oaktree Capital Management, L.P. A Tranche A Term Loan of $55.0 million was funded at signing, which was used to repay $45.0 million of outstanding indebtedness and associated fees. This new facility features interest-only payments and is expected to reduce principal debt repayments over the next three years from $45 million to zero, along with a reduced interest rate compared to the previous agreement. Additional tranches of $20.0 million, $25.0 million, and up to $50.0 million are available upon specific conditions, such as FDA approval of Anaphylm and sales milestones.

Operational Metrics

Doses manufactured/shipped: Approximately 33 million doses were manufactured in Q1 2026, an increase from approximately 27 million doses in Q1 2025. Specifically, 33,320 (000’S) doses were shipped in Q1 2026.
Commercial Infrastructure: The company expanded its planned field force for Anaphylm to approximately 75 sales representatives, marking a 50% increase from prior guidance.

Outlook / Guidance

Aquestive Therapeutics, Inc. reaffirms its guidance to resubmit the Anaphylm™ (dibutepinephrine) sublingual film NDA in Q3 2026, with existing clinical data deemed sufficient for regulatory submissions in Canada, the European Union, and the United Kingdom. The full-year 2026 financial guidance remains unchanged, projecting total revenue between $46 million and $50 million, and a non-GAAP adjusted EBITDA loss between - $35 million and - $30 million. The company also anticipates a projected cash runway extending into 2027, with the debt refinancing providing flexibility for the potential launch of Anaphylm and future growth.