Aquestive Therapeutics (AQST) risk factors, FY2025 10-K

Risks Related to Development and Commercialization of Our Products and Product Candidates

1. 01We cannot be certain that we will be able to successfully develop our product candidates or obtain regulatory approval for our product candidates, including following the CRL we received for Anaphylm93% rewritten
2. 02efficacy and monitor its safety throughout the process. If development within these parameters is unsuccessful, our business could be harmed, and our stock price could be adversely affectedNew
3. 03Clinical trials may be delayed, suspended or terminated for many reasons, which will increase our expenses and delay the time it takes to develop our product candidates
4. 04We have limited commercialization experience and may lack the necessary expertise, personnel and resources to successfully commercialize our other product candidates that must first receive regulatory approval, either on our own or together with collaborators
5. 05Our success depends upon attaining significant market acceptance of our licensed products and proprietary products and product candidates, if approved, among patients, physicians, pharmacists and the medical community
6. 06We could incur substantial costs and disruption to our business and delays in the launch of our product candidates if our competitors and/or collaborators bring legal actions against us, which could harm our business and operating results
7. 07Guidelines and recommendations published by government agencies can reduce the use of our products or product candidates
8. 08We face significant competition from other pharmaceutical companies, and our operating results will suffer if we fail to compete effectively
9. 09If we are unable to achieve and maintain coverage and adequate reimbursement from third-party payors for our licensed products or product candidates, if approved, their commercial success may be severely hindered
10. 10Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws49% rewritten
11. 11Changes in U.S. government policies, including those with respect to China, increased tariffs, and reductions in federal research funding, could adversely affect our businessNew
12. 12including Canada, Mexico, and China, and the temporary freeze on federal grants and loans, may have an adverse impact on our businessNew

Risks Related to Our Financial Condition and Need for Additional Capital

1. 13We have incurred significant losses since our inception and anticipate that we will continue to incur significant losses for the foreseeable future and may never achieve or maintain profitability
2. 14We may sell additional equity, incur debt or raise funds through licensing arrangements to fund our operations, which may result in dilution to our stockholders, impose restrictions on our business or require us to relinquish proprietary rights38% rewritten
3. 15In November 2020, we began utilizing the ATM facility. For the year ended December 31, 2025, we sold 7,457,627 shares which provided net proceeds of approximately $21,229, after deducting commissions and other transaction costs of $77138% rewritten
4. 16Even if we can generate revenues from our operations in the future, our revenues and operating income are likely to fluctuate significantly from year-to-year or quarter-to-quarter and create volatility in our stock price
5. 17Our level of indebtedness and significant debt service obligations could constrain our ability to invest in our business and make it more difficult for us to fund our operations
6. 18We are dependent upon the commercial success of our licensed and proprietary products and other licensing activities to generate revenue for the near future
7. 19A substantial portion of our revenues is derived from a single customer and license and any loss or material reduction in revenues from such significant customer would adversely affect our business
8. 20Although Suboxone has continued to retain meaningful market share, we expect erosion of this sunsetting branded product over time, which will further affect our total revenues and our results from operations47% rewritten

Risks Related to Our Reliance on Third Parties

1. 21We rely on limited sources of supply for our thin film foil, and any disruption in the chain of supply may impact production and sales and cause delay in developing and commercializing our proprietary PharmFilm Technology product candidates
2. 22We currently rely, and expect to continue to rely, on third parties to manufacture API for our licensed products and our product candidates, and control only certain aspects of their activities
3. 23The design, development, manufacture, supply, and distribution of our licensed products and our product candidates is highly regulated and technically complex
4. 24We may not be successful in establishing development and commercialization collaborations, which could adversely affect, and potentially prohibit, our ability to develop our product candidates37% rewritten
5. 25unable to successfully develop and seek regulatory approval for our product or product candidates and/or effectively market and sell approved products, if any, in all of the territories outside of the United States where it may otherwise be valuable to do soNew

Risks Related to Our Business Operations and Industry

1. 26We may experience difficulties in managing growth if our business expands to meet future needs, which could disrupt our operations
2. 27Our licensed products and, if approved, product candidates, may give rise to potential product liability claims or false marketing claims, and, if successful claims are brought against us, we may incur substantial liability
3. 28We may not be able to maintain insurance coverage, and our existing or any future insurance policies or our own resources may not sufficiently cover claims for damages that we may receive in the future
4. 29We rely significantly on information technology and any failure, inadequacy, interruption or security lapse of that technology, including any cybersecurity incidents (including those facilitated by AI) , could harm our ability to operate our business effectively
5. 30Our use of artificial intelligence technologies could expose us to operational, legal, regulatory, and reputational risks and could adversely affect our businessNew
6. 31auditors, collaborators, or customers, we may face remediation obligations, delays, warning letters, recalls, reputational damage, or litigationNew
7. 32If we do not effectively develop, adopt, and govern AI technologies, we may be less competitive and our operating results could sufferNew
8. 33Business interruptions at our manufacturing facilities could delay us in the process of developing our product candidates
9. 34Our R&D activities could be affected or delayed as a result of possible restrictions on animal testing
10. 35Our operations involve hazardous materials and we and third parties with whom we contract must comply with environmental laws and regulations, which can be expensive and restrict how we do business

Risks Related to Government Regulation

1. 36Any of the above described events could prevent us from achieving or maintaining market acceptance of the affected product or product candidate, significantly affect our revenues and profitability from such products, and could substantially increase the costs of commercializing our products and product candidatesNew
2. 37Our business is subject to extensive regulatory requirements and our approved products and product candidates that obtain regulatory approval will be subject to ongoing and continued regulatory review, which may result in significant expense and limit our ability to commercialize such products
3. 38Regulatory approval is required for each of our products in each jurisdiction in which we intend to market or license such products, and the inability to obtain such approvals would limit our ability to realize their full market potential
4. 39If we fail to develop, acquire or in-license other product candidates or products, our business and prospects will be limited
5. 40Public concern regarding the safety of any of our drug products could result in the inclusion of unfavorable information in our labeling or require us to undertake other activities that may entail additional costs

Risks Related to Our Intellectual Property

1. 41If we are unable to obtain or protect intellectual property rights of any of our products and product candidates, we may not be able to compete effectively in our market
2. 42We may enjoy only limited geographical protection with respect to certain patents and we may not be able to protect our intellectual property rights throughout the world
3. 43intellectual property rights important for our business in such jurisdictions, the value of these rights may be diminished, and we may face additional competition from others in those jurisdictionsNew
4. 44Patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents
5. 45We have in the past and are likely in the future to be, involved in lawsuits to protect or enforce our patents. These lawsuits are expensive and require us to expend substantial financial resources, are time consuming, may continue for many years for one or more claims and may be unsuccessful25% rewritten
6. 46may be considered insufficient to cover our products or product candidates. If any of those scenarios were to occur, we might lose our competitive advantage in our market, and our business could be materially affectedNew
7. 47Third parties may commence legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a negative impact on the success of our business60% rewritten
8. 48Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by government patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements81% rewritten
9. 49Our success will depend in part on our ability to operate without infringing the intellectual property and proprietary rights of third parties. We cannot assure you that our business, products, product candidates and methods do not or will not infringe the patents or other intellectual property rights of third parties
10. 50We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
11. 51Intellectual property rights do not necessarily address all potential threats to our competitive advantage

Risks Related to Ownership of Our Common Stock

1. 52Our quarterly operating results may fluctuate significantly, and these fluctuations could cause our stock price to decline
2. 53Our largest stockholder and management own a significant percentage of our stock and may have the ability to effectively influence matters subject to stockholder approval31% rewritten
3. 54Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited
4. 55We do not intend to pay dividends on our Common Stock so any returns will be limited to the value of our stock
5. 56Public health threats such as a global pandemic, or widespread outbreak of infectious disease, similar to the COVID-19 pandemic, may create uncertainties about our future operating results and financial conditions
6. 57Our future success depends on our ability to retain key executives and to attract, retain and motivate qualified personnel
7. 58Under applicable employment laws, we may not be able to enforce covenants not to compete38% rewritten
8. 59Our colleagues, principal investigators, consultants and agents may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading
9. 60We may be subject to claims that our colleagues, consultants or independent contractors have wrongfully used or disclosed confidential information of third parties
10. 61The market price of our Common Stock may be volatile and fluctuate substantially, which could result in substantial losses for purchasers of our Common Stock
11. 62If securities analysts do not publish research or reports about our business or if they publish negative evaluations of our Company, the price of our Common Stock could decline
12. 63We are a “smaller reporting company”, and we cannot be certain if the reduced reporting requirements applicable to smaller reporting companies will make our Common Stock less attractive to investors
13. 64Sales of a substantial number of shares of our Common Stock in the public market by our existing stockholders would cause our stock price to fall
14. 65Adverse developments affecting the financial services industry could adversely affect our current and projected business operations and our financial conditions and results of operation