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Aquestive Therapeutics Inc

For the period ended Dec 31, 2023. Filed Mar 5, 2024.

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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.

FY2023 · Filed Mar 5, 2024

AQST$3.61-1.4%Stored close · as of Nov 6, 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, 2023

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)

Delaware82-3827296
(State or Other Jurisdiction of Incorporation or Organization)(I.R.S. Employer Identification Number)
30 Technology Drive, Warren, NJ07059
(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 classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.001 per shareAQSTNASDAQ 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 7(a)(2)(B) of the Securities Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes S No

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. 7263(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). ☐

As of June 30, 2023, the last 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 $82.7 milllion 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 1, 2024 was 73,301,201.

The registrant intends to file a definitive proxy statement pursuant to Regulation 14A in connection with its 2024 Annual Meeting of Shareholders within 120 days of the end of its fiscal year ended December 31, 2023. 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 I7
Item 1.Business9
Item 1A.Risk Factors29
Item 1B.Unresolved Staff Comments67
Item 1C.Cybersecurity67
Item 2.Properties67
Item 3.Legal Proceedings67
Item 4.Mine Safety Disclosures67
PART II67
Item 5.Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities67
Item 6.Reserved68
Item 7.Management’s Discussion and Analysis of Financial Condition and Results of Operations69
Item 7A.Quantitative and Qualitative Disclosures about Market Risk80
Item 8.Financial Statements and Supplementary Data80
Item 9.Changes in and Disagreements with Accountants on Accounting and Financial Disclosure80
Item 9A.Controls and Procedures80
Item 9B.Other Information81
Item 9C.Disclosure Regarding Foreign Jurisdictions That Prevent Inspections81
PART III82
Item 10.Directors, Executive Officers and Corporate Governance82
Item 11.Executive Compensation82
Item 12.Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters82
Item 13.Certain Relationships and Related Transactions, and Director Independence82
Item 14.Principal Accounting Fees and Services82
PART IV83
Item 15.Exhibits, Financial Statement Schedules83

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:

TERMDEFINITION
12.5% Notes12.5% Senior Secured Notes due 2025
13.5% Notes13.5% Senior Secured Notes
ADHDAttention deficit hyperactivity disorder
ALSAmyotrophic lateral sclerosis
ANDAAbbreviated New Drug Application
ANVISABrazilian Health Regulatory Agency
APIActive Pharmaceutical Ingredients
AQSTCommon Stock symbol for Aquestive Therapeutics, Inc.
AROAsset Retirement Obligations
ASCAccounting Standards Codification
AssertioAssertio Holdings, Inc.
Assertio AgreementLicense Agreement between Aquestive and Otter Pharmaceuticals, LLC, a subsidiary of Assertio Holdings,
ASUAccounting Standards Updates
ATMAt-The-Market facility for the purchase of AQST Common Stock
Base IndentureIndenture for the 12.5% Notes
BBABipartisan Budget Act of 2018
BDSIBioDelivery Sciences International, Inc.
cGMPcurrent Good Manufacturing Practices
CNSCentral Nervous System
Common StockCommon Stock, par value $0.001 per share, of the Company
Common Stock WarrantsWarrants issued with private placement of up to $100,000 aggregate principal of 12.5% Notes originally due 2025
COSOCommittee of Sponsoring Organization of the Treadway Commission
CRLComplete Response Letter (FDA)
CROsContract research organizations
DEADrug Enforcement Agency
DSCSADrug Supply Chain Security Act
EMAEuropean Medicines Agency
ERTCEmployee Retention Tax Credit
EUEuropean Union
Exchange ActSecurities Exchange Act of 1934
Existing WarrantsCommon Stock Purchase Warrants with the holder of the remaining 5,000,000 warrants
FASBFinancial Accounting Standards Board
FDAU.S. Food and Drug Administration
FDAAAThe Food and Drug Administration Amendments Act of 2007
FDICFederal Deposit Insurance Corporation
FDIIForeign Derived Intangible Income
First AmendmentFirst amendment to the Sunovion License Agreement
FortoviaFortovia Therapeutics Inc. (previously Midatech Pharma PLC
FQHCFederally Qualified Health Center
GAAPGenerally Accepted Accounting Principles
GLPGood Laboratory Practice
HaiscoHaisco Pharmaceutical Group Co., Ltd.
Haisco AgreementLicense, Development and Supply Agreement with Haisco, a Chinese limited company listed on the Shenzhen Stock Exchange
HHSU.S. Department of Health and Human Services
HIPAAHealth Insurance Portability and Accountability Act of 1996
HITECHHealth Information Technology for Economic and Clinical Health Act
INDInvestigational New Drug Application
Indenture AgreementAgreement governing the 13.5% Senior Secured Notes
IndiviorIndivior Inc. (formerly, Reckitt Benckiser Pharmaceuticals Inc)
Indivior Amendment 11Amendment No. 11 to the Indivior License Agreement
Indivior License AgreementCommercial Exploitation Agreement with Reckitt Benckiser Pharmaceuticals, Inc. (with subsequent amendments collectively)
IRBInstitutional Review Board
Lincoln ParkLincoln Park Capital Fund, LLC
Lincoln Park Purchase AgreementPurchase Agreement with Lincoln Park Capital Fund, LLC
MarathonMarathon Asset Management
Monetization AgreementPurchase and Sale Agreement between Aquestive and Sunovion
MSSPManaged Security Services Provider
MTHAMitsubishi Tanabe Pharma Holdings America, Inc.
N/MNot Meaningful, used in percentage changes
NasdaqThe Nasdaq Stock Market
NDANew Drug Application
New WarrantsWarrants to purchase 2,750,000 shares of Common Stock
NIHNational Institutes of Health
PDPharmacodynamics
PDUFAPrescription Drug User Fee Act
PharmanoviaAtnahs Pharma UK Limited, a company registered in England and Wales
Pharmanovia AgreementLicense and Supply Agreement with Atnahs Pharma UK Limited,
Pharmanovia AmendmentAmended License and Supply Agreement with Atnahs Pharma UK Limited as of March 27,2023
PKPharmacokinetic
PPACAPatient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010
PTOUnited States Patent and Trademark Office
REMSRisk Evaluation and Mitigation Strategy
Royalty ObligationsLiability related to the Royalty Rights Agreements
Royalty Rights AgreementsRoyalty Rights Agreements, component of 13.5% Senior Secured Notes
RSURestricted Stock Unit
SECSecurities and Exchange Commission
Securities Purchase AgreementsSecurities Purchase Agreements with certain purchasers entered into on June 6, 2022
Separation AgreementSeparation Agreement, including a Consulting Agreement with Keith J. Kendall
SunovionSunovion Pharmaceuticals Inc
Sunovion License AgreementKYNMOBI Commercialization Agreement
TerritoryCertain countries of the European Union, the United Kingdom, Switzerland, Norway and the Middle East and North Africa under the Pharmanovia Agreement
TGAAustralian Government Department of Health’s Therapeutics Goods Administration
ZambonZambon S.p.A.
ZevraZevra Therapeutics, Inc. (formerly KemPharm, Inc.)
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