Aquestive Therapeutics Reports Second Quarter 2026 Financial Results
Aquestive Therapeutics, Inc. (AQST) filed an SEC Form 8-K — Results of Operations and Financial Condition. Exhibit 99.1 Aquestive Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update • Successfully completed human factors validation study and pharmacokinetic study for Anaphylm™ (dibutepinephrine) sublingual film • Remains on track to resubmit Anaphyl
How this was made
The 30-second read
Why it matters
The company states it completed the human factors validation study and PK study to address CRL deficiencies, with preliminary PK endpoint success and no administration errors or serious adverse events in the self-administration arm. It reaffirms resubmission in Q3 2026 and outlines ex-U.S. filing plans.
Market read
This 8-K is a regulatory progress update that can shift traders’ probability-weighting for Anaphylm’s FDA path, especially with a reaffirmed Q3 2026 resubmission timeline.
What to watch
The 8-K reiterates guidance but does not provide new FDA decision dates; traders may over-weight the study results versus the remaining regulatory review uncertainty.
Aquestive Therapeutics Reports Second Quarter 2026 Financial Results and Provides Business Update
Revenue increased 38% to $13.8 million and non-GAAP adjusted EBITDA loss improved to $5.2 million, but GAAP net loss widened to $22.9 million following an $11.7 million loss on extinguishment of debt. The Company maintained its 2026 outlook and remains on track for an Anaphylm NDA resubmission in Q3 2026.
Key metrics
shortened, hover for the filing’s print| Metric | Value | q/q | y/y |
|---|---|---|---|
| Total revenuesGAAP | $13.8M | – | 38% |
| Manufacture and supply revenueGAAP | $11.9M | – | – |
| License and royalty revenueGAAP | $1.3M | – | – |
| Manufacture and supply expensesGAAP | $4.02M | – | – |
| Gross Margin on total revenueGAAP | 71 % | – | – |
| Non-GAAP adjusted manufacture and supply expensesnon-GAAP | $3.84M | – | – |
| Non-GAAP Gross Margin on total revenuenon-GAAP | 72 % | – | – |
| Research and development expensesGAAP | $4M | – | – |
| Non-GAAP adjusted research and development expensesnon-GAAP | $3.63M | – | – |
| Selling, general and administrative expensesGAAP | $14.1M | – | – |
| Non-GAAP adjusted selling, general and administrative expensesnon-GAAP | $11.53M | – | – |
| Total costs and expensesGAAP | $22.04M | – | – |
| Non-GAAP adjusted costs and expensesnon-GAAP | $19.01M | – | – |
| Loss from operationsGAAP | −$8.22M | – | – |
| Loss on extinguishment of debtGAAP | $(11.7 million) | – | – |
| Interest expenseGAAP | −$2.81M | – | – |
| Interest expense related to royalty obligationsGAAP | −$972K | – | – |
| Interest expense related to the sale of future revenueGAAP | −$61K | – | – |
| Interest income and other income, netGAAP | $882K | – | – |
| Net loss before income taxesGAAP | −$22.86M | – | – |
| Net lossGAAP | $22.9M | – | – |
| Basic and diluted loss per shareGAAP | $0.18 for both basic and diluted loss per share | – | – |
| Non-GAAP adjusted EBITDA lossnon-GAAP | $5.2M | – | – |
| Net loss excluding the impact of the one-time recognition of the loss on extinguishment on the Company's 13.5% Notesother | $11.2M | – | – |
| Six Months Ended June 30 revenuesGAAP | $28.27M | – | – |
| Six Months Ended June 30 loss from operationsGAAP | −$12.43M | – | – |
| Six Months Ended June 30 net lossGAAP | −$30.92M | – | – |
| Six Months Ended June 30 basic and diluted loss per shareGAAP | $(0.25) (in dollars per share) | – | – |
| Six Months Ended June 30 non-GAAP adjusted EBITDAnon-GAAP | −$6.96M | – | – |
Segments
| Segment | Revenue | q/q | y/y |
|---|---|---|---|
| Manufacture and supply revenuePrimarily due to increases in Suboxone revenues, partially offset by lower Ondif revenues. | $11.9M | – | – |
| License and royalty revenuePrimarily due to royalty revenue from Zevra. | $1.3M | – | – |
full-year 2026 outlook
- Revenue$46 to $50
- NoteNon-GAAP adjusted EBITDA loss (in millions): $35 to $30
- NoteResubmit the Anaphylm New Drug Application (NDA) in the third quarter of 2026.
- NoteSubmit regulatory applications in Canada by the end of 2026.
- NoteSubmit regulatory applications in the European Union in the first quarter of 2027.
- NoteExisting clinical data is expected to support regulatory submissions in additional markets in 2027, including the United Kingdom.
- NoteLibervant is expected to become eligible for full approval following the expiration in January 2027 of the orphan drug exclusivity protecting another company's FDA-approved product.
What drove it
- The Company completed the human factors validation study and pharmacokinetic study required to address deficiencies identified in the January 30, 2026 Complete Response Letter for Anaphylm.
- Based on preliminary data, the Anaphylm PK study met its primary endpoints. No administration errors were observed in the self-administration arm, and there were no serious adverse events or events that led to study drug discontinuation.
- The Company manufactured approximately 48 million doses in the second quarter 2026, compared to approximately 37 million doses in the second quarter 2025.
- Manufacture and supply revenue increased primarily due to increases in Suboxone revenues, partially offset by lower Ondif revenues.
- License and royalty revenue increased primarily due to royalty revenue from Zevra.
- R&D expense declined primarily because of lower development and manufacturing costs associated with Anaphylm, partially offset by increased preclinical costs.
- GAAP gross margin on total revenue was 71 %, compared with 54 % in the second quarter of 2025.
Concerns
- The Company recognized a one-time loss on extinguishment of debt of $11.7 million in the second quarter 2026.
- Selling, general and administrative expenses increased to $14.1 million from $12.7 million, including higher legal fees of approximately $2.1 million, higher severance costs of approximately $1.4 million, higher personnel costs of approximately $0.9 million, and higher share-based compensation expenses of approximately $0.3 million.
- Interest income and other income, net declined to $882 (in thousands) from $2,096 (in thousands).
- The Company will request an expedited review upon Anaphylm NDA resubmission, though no shortened or expedited review timeline can be guaranteed.
- Libervant remains tentatively approved in the United States for epilepsy patients ages 12 years and older and is expected to become eligible for full approval following the expiration in January 2027 of orphan drug exclusivity protecting another company's FDA-approved product.
- The Company identifies Suboxone as a sunsetting product that accounts for a substantial part of current operating revenue.
What to watch
- Resubmission of the Anaphylm NDA in the third quarter of 2026 and the FDA's response, including any decision on expedited review.
- Anaphylm regulatory applications in Canada by the end of 2026 and in the European Union in the first quarter of 2027.
- Commercial readiness and payer engagement for a potential focused, allergist-first Anaphylm launch.
- Further development of AQST-108 in dermatologic inflammatory indications, including atopic dermatitis.
- The January 2027 expiration of the orphan drug exclusivity affecting potential Libervant full approval for patients ages 12 years and older.
- Execution against full-year 2026 guidance of total revenue of $46 to $50 and non-GAAP adjusted EBITDA loss of $35 to $30.
Balance sheet and cash flow
- Cash and cash equivalents were $98.5 million as of June 30, 2026.
- Cash and cash equivalents: $98,490 (in thousands) at June 30, 2026, compared with $121,169 (in thousands) at December 31, 2025.
- Trade and other receivables, net: $9,326 (in thousands) at June 30, 2026, compared with $17,763 (in thousands) at December 31, 2025.
- Inventories: $7,366 (in thousands) at June 30, 2026, compared with $6,169 (in thousands) at December 31, 2025.
- Total assets: $132,104 (in thousands) at June 30, 2026, compared with $160,425 (in thousands) at December 31, 2025.
- Debt, current: $32 (in thousands) at June 30, 2026, compared with $9,994 (in thousands) at December 31, 2025.
- Debt, long-term, net: $50,654 (in thousands) at June 30, 2026, compared with $27,519 (in thousands) at December 31, 2025.
- Royalty obligations, net: $27,835 (in thousands) at June 30, 2026, compared with $25,941 (in thousands) at December 31, 2025.
- Liability related to the sale of future revenue, net: $61,168 (in thousands) at June 30, 2026, compared with $62,023 (in thousands) at December 31, 2025.
- Total liabilities: $188,690 (in thousands) at June 30, 2026, compared with $194,087 (in thousands) at December 31, 2025.
- Total stockholders’ deficit: $(56,586) (in thousands) at June 30, 2026, compared with $(33,662) (in thousands) at December 31, 2025.
Analysis
Second-quarter revenue increased 38% to $13.8 million from $10.0 million. Growth was led by manufacture and supply revenue of $11.9 million, primarily reflecting higher Suboxone revenues, partly offset by lower Ondif revenues. License and royalty revenue reached $1.3 million, with the increase primarily due to Zevra royalty revenue. The manufacturing operation produced approximately 48 million doses, compared with approximately 37 million doses in the prior-year quarter.
Margin and operating trends improved despite higher overhead. GAAP gross margin on total revenue was 71 %, compared with 54 %, while non-GAAP gross margin was 72 %, compared with 57 %. Manufacture and supply expenses declined to $4,017 (in thousands) from $4,561 (in thousands), and R&D expenses declined to $4.0 million from $4.1 million. Selling, general and administrative expenses rose to $14.1 million from $12.7 million, driven by higher legal fees, severance costs, personnel costs and share-based compensation, partly offset by lower commercial spending and lower regulatory and licensing fees.
The GAAP net loss widened to $22.9 million, or $0.18 for both basic and diluted loss per share, from $13.5 million, or $0.14 for both basic and diluted loss per share. The principal factor was the $11.7 million one-time loss on extinguishment of debt. Excluding that item, net loss was $11.2 million. Non-GAAP adjusted EBITDA loss improved to $5.2 million from $9.3 million. Cash and cash equivalents were $98.5 million as of June 30, 2026, while long-term debt, net was $50,654 (in thousands) and the stockholders’ deficit was $(56,586) (in thousands).
The strategic focus remains Anaphylm. The Company completed the human factors validation and PK studies intended to address the January 30, 2026 CRL, stated that preliminary PK data met primary endpoints, and reaffirmed a Q3 2026 NDA resubmission. The Company is conducting medical-affairs, market-access and launch-preparation activities while pursuing filings in Canada by the end of 2026 and the European Union in the first quarter of 2027. FDA review timing remains a central uncertainty because the Company will request, but cannot guarantee, expedited review.
AQST-108 adds an earlier-stage pipeline option following completion of a Phase 1 study in androgenic alopecia with no safety concerns observed, while the program expands into atopic dermatitis and other dermatologic inflammatory indications. Libervant remains subject to its tentative-approval status and the January 2027 expiration of another company's orphan drug exclusivity. Financial guidance was unchanged at total revenue of $46 to $50 and non-GAAP adjusted EBITDA loss of $35 to $30 for full-year 2026.
Management, verbatim
As we bring Anaphylm to market, if approved by the FDA, we believe we can be instrumental in driving conversion in the allergist office and, ultimately, the broader market.
Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics
As we prepare to resubmit our application to the FDA in the coming weeks, our full attention will be to prepare for a focused, allergist-first launch of Anaphylm as quickly as possible, if approved by the FDA.
Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics
Although AQST-108 is still in early-stage development, we are encouraged by the emerging data and plan on continuing to advance the program as we look towards 2027.
Daniel Barber, President and Chief Executive Officer of Aquestive Therapeutics
Not in the filing
stated, not guessed- Prior-quarter comparisons for reported quarterly financial metrics
- Operating cash flow
- Free cash flow
- Capital expenditures
- Share repurchases
- Dividends
- GAAP gross-margin outlook
- Operating-expense outlook
- Tax-rate outlook
- Previous-release outlook for comparison with actual results
AlphAI analysis generated from the company’s SEC earnings filing (Form 8-K Item 2.02, or Form 6-K for a foreign private issuer). Every figure was cross-checked against the filing text; consensus estimates, price targets and share-price reactions are not shown because they are not in the filing. AI-generated research, not investment advice.
Background
Aquestive’s Anaphylm (dibutepinephrine) received an FDA Complete Response Letter on Jan 30, 2026, prompting required packaging and related work before resubmission.
Ticker impact
AQST reports Q2 2026 Anaphylm progress, including completion of human factors and PK studies and reaffirmed NDA resubmission in Q3 2026.
Bias upward into the Q3 2026 resubmission window, with volatility around any FDA feedback or resubmission execution details.
The filing is a primary 8-K with concrete regulatory-study outcomes and a reiterated resubmission schedule, which can re-rate probability of approval and launch readiness.
Market effects
Reinforces investor appetite for non-invasive epinephrine delivery platforms and FDA re-engagement after a CRL, potentially lifting sentiment for similar specialty pharma programs.
Limited direct regional read-through; mentions Canada and EU filing timelines for Anaphylm.
Moderate, as the update includes planned ex-U.S. regulatory submissions (Canada by end-2026, EU in Q1 2027) that can broaden the addressable market narrative.
Counterpoint
Even with improved human factors and PK endpoints, FDA expedited review is requested but not guaranteed, so approval timing risk remains high.
Key entities
- companyAquestive Therapeutics, Inc.
NASDAQ-listed pharma company advancing Anaphylm and the AdrenaVerse epinephrine prodrug platform.
- product_candidateAnaphylm (dibutepinephrine) sublingual film
Oral epinephrine product candidate for type I allergic reactions, including anaphylaxis, targeted for FDA resubmission in Q3 2026.
- product_candidateAQST-108 (epinephrine) topical gel
Topical epinephrine prodrug gel in early development for dermatologic indications, including atopic dermatitis.
- regulatorFDA
Regulatory authority that issued the Jan 30, 2026 Complete Response Letter and will review the forthcoming NDA resubmission.
