Aquestive Therapeutics, Inc.
For the period ended Dec 31, 2025. Filed Mar 4, 2026.
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A company's yearly report to the SEC, with audited financial statements. It is the fullest account a company gives of its business, its finances and the risks it sees.
FY2025 · Filed Mar 4, 2026
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-K
(Mark One)
For the fiscal year ended December 31, 2025
OR
| ☐ | TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
|---|
For the transition period from _____ to _____
Commission File Number:001-38599
Aquestive Therapeutics, Inc.
(Exact Name of Registrant as Specified in its Charter)
| Delaware | 82-3827296 |
|---|---|
| (State or Other Jurisdiction of Incorporation or Organization) | (I.R.S. Employer Identification Number) |
| 30 Technology Drive, Warren, NJ | 07059 |
| (Address of Principal Executive Offices) | (Zip Code) |
(908)941-1900
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
|---|---|---|
| Common Stock, par value $0.001 per share | AQST | Nasdaq Global Market |
Securities registered pursuant to Section 12(g) of the Act: None
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.£ Yes S No
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.£ Yes S No
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. S Yes £ No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (Section 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). S Yes £ No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Securities Exchange Act of 1934.
| Large accelerated filer | ☐ | Accelerated filer | ☐ |
|---|---|---|---|
| Non-accelerated filer | ☒ | Smaller reporting company | ☒ |
| Emerging growth company | ☐ | ||
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided to Section 13(a) of the Securities Act. ☐
Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.☐
If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements.☐
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to Section 240.10D-1(b). ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes S No
As of June 30, 2025, the last business day of the registrant’s most recently completed second fiscal quarter, the aggregate market value of the common stock held by non-affiliates of the registrant was approximately $291.6 million based on the closing price of the registrant’s common stock on such date.
The number of outstanding shares of the registrant’s par value $0.001 common stock as of the close of business on March 2, 2026 was 122,045,049.
The registrant intends to file a definitive proxy statement pursuant to Regulation 14A in connection with its 2026 Annual Meeting of Shareholders within 120 days of the end of its fiscal year ended December 31, 2025. Portions of such definitive proxy statement are incorporated by reference into Part III of this Annual Report on Form 10-K.
| Page No. | ||
|---|---|---|
| Glossary of Terms, Abbreviations and Acronyms | ||
| PART I | 1 | |
| Item 1. | Business | 3 |
| Item 1A. | Risk Factors | 23 |
| Item 1B. | Unresolved Staff Comments | 60 |
| Item 1C. | Cybersecurity | 60 |
| Item 2. | Properties | 61 |
| Item 3. | Legal Proceedings | 61 |
| Item 4. | Mine Safety Disclosures | 61 |
| PART II | 61 | |
| Item 5. | Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities | 61 |
| Item 6. | Reserved | 61 |
| Item 7. | Management’s Discussion and Analysis of Financial Condition and Results of Operations | 62 |
| Item 7A. | Quantitative and Qualitative Disclosures about Market Risk | 73 |
| Item 8. | Financial Statements and Supplementary Data | 73 |
| Item 9. | Changes in and Disagreements with Accountants on Accounting and Financial Disclosure | 73 |
| Item 9A. | Controls and Procedures | 73 |
| Item 9B. | Other Information | 74 |
| Item 9C. | Disclosure Regarding Foreign Jurisdictions That Prevent Inspections | 74 |
| PART III | 75 | |
| Item 10. | Directors, Executive Officers and Corporate Governance | 75 |
| Item 11. | Executive Compensation | 75 |
| Item 12. | Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters | 75 |
| Item 13. | Certain Relationships and Related Transactions, and Director Independence | 75 |
| Item 14. | Principal Accounting Fees and Services | 75 |
| PART IV | 76 | |
| Item 15. | Exhibits, Financial Statement Schedules | 76 |
GLOSSARY OF TERMS, ABBREVIATIONS AND ACRONYMS
The following terms, abbreviations and acronyms are used to identify frequently used terms and phrases that may be used in this report:
| TERM | DEFINITION |
|---|---|
| 12.5% Notes | 12.5% Senior Secured Notes redeemed on November 1, 2023 |
| 13.5% Notes | 13.5% Senior Secured Notes |
| 2024 Underwritten Public Offering | Capital raise of gross proceeds of $77,519, including partial exercise of the underwriters' option for $2,519 |
| 2025 Underwritten Public Offering | Capital raise of gross proceeds of $85,000 |
| ABL | Asset-Based Lending |
| ADHD | Attention Deficit Hyperactivity Disorder |
| AED | Antiepileptic drug |
| AI | Artificial Intelligence |
| ALS | Amyotrophic Lateral Sclerosis |
| Amendment | Amendment No. 1 to the Purchase and Sale Agreement |
| ANDA | Abbreviated New Drug Application |
| ANVISA | Brazilian Health Regulatory Agency |
| API | Active Pharmaceutical Ingredients |
| AQST | Common Stock symbol for Aquestive Therapeutics, Inc. |
| ARO | Asset Retirement Obligations |
| ARS | Acute Repetitive Seizures |
| ASC | Accounting Standards Codification |
| Assertio | Assertio Holdings, Inc. |
| Assertio Agreement | License Agreement between Aquestive and Otter Pharmaceuticals, LLC, a subsidiary of Assertio Holdings, |
| ASU | Accounting Standards Updates |
| ATM | At-The-Market facility for the purchase of AQST Common Stock |
| Audit Committee | Audit Committee of the Board of Directors |
| BBA | Bipartisan Budget Act of 2018 |
| cGMP | current Good Manufacturing Practices |
| CMC | Chemistry, Manufacturing and Controls |
| CMS | Centers for Medicare & Medicaid Services |
| CNS | Central Nervous System |
| CODM | Chief Operating Decision Maker |
| Common Stock | Common Stock, par value $0.001 per share, of the Company |
| Common Stock Warrants | Warrants issued with private placement of up to $100,000 aggregate principal of 12.5% Notes originally due 2025 |
| CSIRT | Company’s Cybersecurity Incident Response Team |
| Cosmed | CosMed Industria De Cosmeticos E Medicamentos S.A |
| COSO | Committee of Sponsoring Organization of the Treadway Commission |
| CRL | Complete Response Letter (FDA) |
| CROs | Contract research organizations |
| DEA | Drug Enforcement Agency |
| DSCSA | Drug Supply Chain Security Act |
| EBIT | Earnings before interest and taxes |
| EMA | European Medicines Agency |
| EoP2 | End-of-Phase 2 |
| EPO | European Patent Office |
| EPS | Earnings (loss) per share |
|---|---|
| ERTC | Employee Retention Tax Credit |
| ESPP | Employee Stock Purchase Plan |
| EU | European Union |
| Exchange Act | Securities Exchange Act of 1934 |
| Existing Warrants | Common Stock Purchase Warrants with the holder of the remaining 5,000,000 warrants |
| FASB | Financial Accounting Standards Board |
| FDA | U.S. Food and Drug Administration |
| FDAAA | The Food and Drug Administration Amendments Act of 2007 |
| FDCA | The Federal Food, Drug, and Cosmetic Act |
| FDIC | Federal Deposit Insurance Corporation |
| FDII | Foreign Derived Intangible Income |
| First Amendment | First amendment to the Sunovion License Agreement |
| GAAP | Generally Accepted Accounting Principles |
| GCP | Good Clinical Practice |
| GLP | Good Laboratory Practice |
| Haisco | Haisco Pharmaceutical Group Co., Ltd. |
| Haisco Agreement | License, Development and Supply Agreement with Haisco, a Chinese limited company listed on the Shenzhen Stock Exchange |
| HCP | Healthcare provider |
| HHS | U.S. Department of Health and Human Services |
| HIPAA | Health Insurance Portability and Accountability Act of 1996 |
| HITECH | Health Information Technology for Economic and Clinical Health Act |
| HF | Human Factors |
| IND | Investigational New Drug Application |
| Indenture Agreement | Agreement governing the 13.5% Senior Secured Notes |
| Indivior | Indivior UK Limited (formerly, Reckitt Benckiser Pharmaceuticals Inc and Indivior Inc.) |
| Indivior Amendment 11 | Amendment No. 11 to the Indivior License Agreement |
| Indivior License Agreement | Commercial Exploitation Agreement with Reckitt Benckiser Pharmaceuticals, Inc. (with subsequent amendments collectively) |
| IM | Intramuscular |
| IRB | Institutional Review Board |
| Lincoln Park | Lincoln Park Capital Fund, LLC |
| Marathon | Marathon Asset Management |
| MHRA | Medicines and Healthcare Products Regulatory Agency |
| Monetization Agreement | Purchase and Sale Agreement between Aquestive and Sunovion |
| MSSP | Managed Security Services Provider |
| MTPA | Mitsubishi Tanabe Pharma Holdings America, Inc. |
| N/M | Not Meaningful, used in percentage changes |
| Nasdaq | The Nasdaq Stock Market |
| NDA | New Drug Application |
| NDS | New Drug Submission |
| New Warrants | Warrants to purchase 2,750,000 shares of Common Stock |
| NIH | National Institutes of Health |
| NIST CSF | National Institute of Standards and Technology Cybersecurity Framework |
| ODE | Orphan Drug Exclusivity |
| PD | Pharmacodynamics |
| PDMA | The U.S. Prescription Drug Marketing Act |
| PDUFA | Prescription Drug User Fee Act |
| Pharmanovia | Atnahs Pharma UK Limited, a company registered in England and Wales |
|---|---|
| Pharmanovia Agreement | License and Supply Agreement with Atnahs Pharma UK Limited, |
| Pharmanovia Amendment | Amended License and Supply Agreement with Atnahs Pharma UK Limited as of March 27, 2023 |
| PK | Pharmacokinetic |
| PPACA | Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 |
| PTO | United States Patent and Trademark Office |
| Purchase and Sale Agreement | Purchase and sale agreement with funds managed by RTW Investments LP |
| Purchaser | RTW Investments LP |
| Purchase Price | $75,000 |
| R&D | Research and development |
| REMS | Risk Evaluation and Mitigation Strategy |
| Royalty Obligations | Liability related to the Royalty Rights Agreements |
| Royalty Rights Agreements | Royalty Rights Agreements, component of 13.5% Senior Secured Notes |
| RTW | RTW Investments, L.P |
| RSU | Restricted Stock Unit |
| SEC | Securities and Exchange Commission |
| Securities Purchase Agreements | Securities Purchase Agreements with certain purchasers entered into on June 6, 2022 |
| Sunovion | Sunovion Pharmaceuticals Inc |
| Sunovion License Agreement | KYNMOBI Commercialization Agreement |
| Territory | Certain countries of the European Union, the United Kingdom, Switzerland, Norway and the Middle East and North Africa under the Pharmanovia Agreement |
| TGA | Australian Government Department of Health’s Therapeutics Goods Administration |
| Zambon | Zambon S.p.A. |
| Zevra | Zevra Therapeutics, Inc. (formerly KemPharm, Inc.) |
The text of this filing, as the company filed it with the SEC, without its images or exhibits. This is not investment advice.