Aquestive Therapeutics Files 2023 Annual Report on Form 10-K

TL;DR

<b>Aquestive Therapeutics filed its 2023 10-K report detailing its fiscal year performance and corporate information.</b>

AI Summary

Aquestive Therapeutics, Inc. (AQST) filed a Annual Report (10-K) with the SEC on March 5, 2024. Aquestive Therapeutics, Inc. filed its 2023 Form 10-K on March 5, 2024. The filing covers the fiscal year ending December 31, 2023. The company's principal executive offices are located at 30 Technology Drive, Warren, NJ 07059. Aquestive Therapeutics was formerly known as MonoSol Rx, Inc., with a name change effective May 7, 2007. The SIC code for the company is 2834, Pharmaceutical Preparations.

Why It Matters

For investors and stakeholders tracking Aquestive Therapeutics, Inc., this filing contains several important signals. This 10-K filing provides a comprehensive overview of Aquestive Therapeutics' financial health, operational activities, and strategic initiatives for the fiscal year 2023, which is crucial for investors to assess the company's performance and future prospects. The detailed information within the 10-K, including financial statements and risk factors, allows stakeholders to understand the company's market position, potential challenges, and regulatory compliance within the pharmaceutical sector.

Risk Assessment

Risk Level: medium — Aquestive Therapeutics, Inc. shows moderate risk based on this filing. The company operates in the pharmaceutical industry, which is subject to significant regulatory oversight, lengthy development cycles, and intense competition, posing inherent risks to its financial performance and market position.

Analyst Insight

Investors should review the detailed financial statements and risk factors in the 10-K to assess Aquestive Therapeutics' financial health and strategic direction for 2024.

Key Numbers

• 2023-12-31 — Fiscal Year End (Conformed period of report)
• 2024-03-05 — Filing Date (Filed as of date)
• 0001398733 — Central Index Key (Filer's central index key)
• 2834 — SIC Code (Standard Industrial Classification)

Key Players & Entities

• Aquestive Therapeutics, Inc. (company) — Filer name
• 2023 (date) — Fiscal year end
• March 5, 2024 (date) — Filing date
• 30 Technology Drive, Warren, NJ 07059 (address) — Business address
• MonoSol Rx, Inc. (company) — Former company name
• May 7, 2007 (date) — Date of name change
• 2834 (industry) — Standard Industrial Classification
• Mark Schobel (person) — Member

FAQ

Industry Context

Aquestive Therapeutics operates in the pharmaceutical industry, focusing on the development and commercialization of differentiated pharmaceutical products, particularly in the area of complex formulations.

Regulatory Implications

The pharmaceutical industry is heavily regulated by bodies such as the FDA, requiring strict adherence to manufacturing standards, clinical trial protocols, and marketing regulations.

What Investors Should Do

1. Review the full 10-K filing for detailed financial statements and management's discussion and analysis.
2. Analyze the risk factors section to understand potential challenges and uncertainties facing the company.
3. Examine any disclosures related to product development, regulatory approvals, and commercialization strategies.

Key Dates

• 2023-12-31: Fiscal Year End — End of the reporting period for the 10-K.
• 2024-03-05: Filing Date — Date the 10-K was officially filed with the SEC.

Year-Over-Year Comparison

This is the initial 10-K filing for the fiscal year 2023. Previous filings would have been for prior fiscal years.

Key Financial Figures

• $0.001 — ich registered Common Stock, par value $0.001 per share AQST NASDAQ Global Market S
• $100,000 — issued with private placement of up to $100,000 aggregate principal of 12.5% Notes orig

Filing Documents

• aqst-20231231.htm (10-K) — 1946KB
• pharmanovialsaamendment0.htm (EX-10.40) — 18KB
• ex231kpmgconsent123123.htm (EX-23.1) — 2KB
• aqst-12312023xexhibit311.htm (EX-31.1) — 13KB
• aqst-12312023xexhibit312.htm (EX-31.2) — 13KB
• aqst-12312023xexhibit321.htm (EX-32.1) — 8KB
• aqst-12312023xexhibit322.htm (EX-32.2) — 8KB
• aquestiveclawbackpolicy926.htm (EX-97) — 37KB
• aqst-20231231_g1.jpg (GRAPHIC) — 90KB
• aqst-20231231_g2.jpg (GRAPHIC) — 155KB
• pharmanovialsaamendment0001.jpg (GRAPHIC) — 233KB
• pharmanovialsaamendment0002.jpg (GRAPHIC) — 233KB
• pharmanovialsaamendment0003.jpg (GRAPHIC) — 36KB
• pharmanovialsaamendment0004.jpg (GRAPHIC) — 66KB
• pharmanovialsaamendment0005.jpg (GRAPHIC) — 212KB
• pharmanovialsaamendment0006.jpg (GRAPHIC) — 141KB
• pharmanovialsaamendment0007.jpg (GRAPHIC) — 186KB
• pharmanovialsaamendment0008.jpg (GRAPHIC) — 212KB
• pharmanovialsaamendment0009.jpg (GRAPHIC) — 79KB
• 0001628280-24-009010.txt (&nbsp;) — 12752KB
• aqst-20231231.xsd (EX-101.SCH) — 85KB
• aqst-20231231_cal.xml (EX-101.CAL) — 98KB
• aqst-20231231_def.xml (EX-101.DEF) — 417KB
• aqst-20231231_lab.xml (EX-101.LAB) — 888KB
• aqst-20231231_pre.xml (EX-101.PRE) — 695KB
• aqst-20231231_htm.xml (XML) — 1162KB

Risk Factors

Item 1A. Risk Factors 29 Item 1B. Unresolved Staff Comments 67 Item 1C. Cybersecurity 67 Item 2.

Properties

Properties 67 Item 3.

Legal Proceedings

Legal Proceedings 67 Item 4. Mine Safety Disclosures 67 PART II 67 Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities 67 Item 6. Reserved 68 Item 7.

Management's Discussion and Analysis of Financial Condition and Results of Operations

Management's Discussion and Analysis of Financial Condition and Results of Operations 69 Item 7A.

Quantitative and Qualitative Disclosures about Market Risk

Quantitative and Qualitative Disclosures about Market Risk 80 Item 8.

Financial Statements and Supplementary Data

Financial Statements and Supplementary Data 80 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 80 Item 9A.

Controls and Procedures

Controls and Procedures 80 Item 9B. Other Information 81 Item 9C . Disclosure Regarding Foreign Jurisdictions That Prevent Inspections 81 PART III 82 Item 10. Directors, Executive Officers and Corporate Governance 82 Item 11.

Executive Compensation

Executive Compensation 82 Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 82 Item 13. Certain Relationships and Related Transactions, and Director Independence 82 Item 14. Principal Accounting Fees and Services 82 PART IV 83 Item 15. Exhibits, Financial Statement Schedules 83 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 due 2025 13.5% Notes 13.5% Senior Secured Notes ADHD Attention deficit hyperactivity disorder ALS Amyotrophic lateral sclerosis 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 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 Base Indenture Indenture for the 12.5% Notes BBA Bipartisan Budget Act of 2018 BDSI BioDelivery Sciences International, Inc. cGMP current Good Manufacturing Practices CNS Central Nervous System 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 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 EMA European Medicines Agency ERTC Employee Retention Tax Credit EU European Union Exchange Act Securities Exchange Act of 1934 Existing Warra

Forward-Looking Statements

Forward-Looking Statements This Annual Report on Form 10-K and certain other communications made by us include forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "believe," "anticipate," "plan," "expect," "estimate," "intend," "may," "will," or the negative of those terms, and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, but are not limited to, statements regarding the advancement and related timing of our product candidate Anaphylm (epinephrine) Sublingual Film through clinical development and approval by the FDA, including filing of a pivotal PK clinical trial and other supporting clinical studies for Anaphylm; our ability to provide sufficient data in our NDA submission for Anaphylm to address FDA feedback on our proposed pivotal PK study protocol and from the End-of-Phase 2 (EOP2) meeting with the FDA; the anticipated PDUFA goal date of April 28, 2024 of our filed NDA for Libervant (diazepam) Buccal Film for the acute treatment of intermittent, stereotypic episodes of frequent seizure activity ( i.e ., seizure clusters, acute repetitive seizures) that are distinct from a patient's usual seizure pattern in patients with epilepsy between two and five years of age; the approval for U.S. market access of Libervant for these epilepsy patients aged two years and older, and overcoming the orphan drug market exclusivity of a competing FDA approved nasal spray product extending to January 2027 for this patient population; the advancement and related timing of our product candidate AQST-108 SF (epinephrine) through the clinical development and regulatory process; the potential outlicensing of our product pipeline in the U.S. and abroad, including with respect to Anaphylm and Libervant; the focus on continuing to manufacture Suboxone , Exservan , Sympazan , Ondif and other licensed products; the potential benefits our products could bri

Business Overview

Item 1. Business Overview Aquestive is a pharmaceutical company advancing medicines to bring meaningful improvement to patients' lives through innovative science and delivery technologies. We are developing pharmaceutical products to deliver complex molecules through administrations that are alternatives to invasive and inconvenient standard of care therapies. We have five licensed commercialized products which are marketed by our licensees in the U.S. and around the world. We are the exclusive manufacturer of these licensed products. Aquestive also collaborates with pharmaceutical companies to bring new molecules to market using proprietary, best-in-class technologies, like PharmFilm , and has proven drug development and commercialization capabilities. We are advancing a product pipeline for the treatment of severe allergic reactions, including anaphylaxis. We have also developed a product pipeline focused on treating diseases of the CNS. Our production facilities are located in Portage, Indiana, and our corporate headquarters and primary research laboratory facilities are based in Warren, New Jersey. We manufacture licensed products at our facilities and anticipate that our current manufacturing capacity is sufficient for commercial quantities of our licensed products and product candidates currently in development. Our facilities have been inspected by the FDA, TGA, and DEA and are subject to inspection by all applicable health agencies, including ANVISA and EMA. Not all collaborative or licensed products of Aquestive that may be commercially launched in the future will necessarily be manufactured by us, such as the case with KYNMOBI. PharmFilm – Our Oral Film Technology We are presently the worldwide leader in oral film drug delivery and manufacturing, having historically supplied the substantial majority of the world's oral films for prescription pharmaceutical use, and we have the capability to produce more than one billion commercial doses a year. We deve

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View this 10-K filing on SEC EDGAR