TG Therapeutics (TGTX) risk factors, FY2025 10-K

Risks Related to Commercialization

1. 01favorable or unfavorable publicity relating to our products or relating to the Company
2. 02We may be subject to limitations on the indicated uses or requirements to fulfill certain post-marketing requirements or commitments to the satisfaction of regulatory authorities or may be unable to maintain marketing approval for BRIUMVI or future products that we may bring to market
3. 03BRIUMVI, and any of our product candidates for which we in the future obtain marketing approval, may, after approval, be found to cause undesirable side effects that could result in significant negative consequences following commercialization
4. 04our reputation may suffer
5. 05We face substantial competition, which may result in others commercializing drugs before or more successfully than we do, resulting in the reduction or elimination of our commercial opportunity
6. 06The key competitive factors affecting the success of all of our drug candidates, if approved, are likely to be their efficacy, safety, convenience, price, the level of generic or biosimilar competition and the availability of reimbursement from government and other third-party payors
7. 07BRIUMVI, as well as any products that we are able to commercialize in the future, may become subject to unfavorable pricing regulations or third-party payor coverage and reimbursement policies, which would harm our business26% rewritten
8. 08Commercialization of pharmaceutical products is an extremely complex and highly capital and resource-intensive process. Even for established companies with existing infrastructure and significantly greater resources than we have, challenges have occurred
9. 09unforeseen costs and expenses associated with creating a commercialization organization23% rewritten
10. 10Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any drug candidates that we may develop
11. 11the inability to commercialize any products or product candidates that we may develop
12. 12Any contracts that we enter into with government entities may involve future funding and compliance risks55% rewritten

Risks Related to Our Financial Position and Need for Additional Capital

1. 13We have incurred substantial operating losses since our inception, and we may incur losses in the future29% rewritten
2. 14While we do not expect to need to raise additional capital, we may need to do so. If we are unable to raise capital, if needed, we may be required to delay, limit, reduce or eliminate some of our drug development programs or commercialization efforts47% rewritten
3. 15the extent to which we in-license or invest in other indications or product candidates
4. 16Raising additional capital may cause dilution to our stockholders, restrict our operations or require us to relinquish rights to our technologies or drug candidates and occupy valuable management time and resources29% rewritten
5. 17Due to limited resources, we may fail to capitalize on programs or product candidates that may present a greater commercial opportunity or for which there is a greater likelihood of success36% rewritten
6. 18Our level of indebtedness and debt service obligations could adversely affect our financial condition and may make it more difficult for us to fund our operations
7. 19We may not have cash available in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due
8. 20Our cash and cash equivalents could be adversely affected if the financial institutions in which we hold our cash and cash equivalents fail

Risks Related to Drug Development and Regulatory Approval

1. 21If we are unable to maintain or obtain regulatory approval for our product or product candidates and ultimately cannot successfully commercialize our product or product candidates, or experience significant delays in doing so, our business will be materially harmed
2. 22If we do not achieve one or more of these factors in a timely manner or at all, we could experience significant delays in our clinical programs and regulatory submission timelines and may not be able to obtain regulatory approval for our product candidates
3. 23Clinical drug development involves a lengthy and expensive process, with an uncertain outcome. We may incur additional costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of our product candidates
4. 24have the drug removed from the market after obtaining marketing approval
5. 25Biologics carry unique risks and uncertainties, which could have a negative impact on our business
6. 26Our product or product candidates may cause undesirable side effects or adverse events that could delay or prevent their regulatory approval or impact their availability and commercial potential after approval
7. 27Any products or product candidates we may advance through clinical development are subject to extensive regulation, which can be costly and time consuming, cause unanticipated delays or prevent the receipt of the required approvals31% rewritten
8. 28interruptions or delays in the operations of the FDA and regulatory authorities outside of the U.S. as a result of global health crises, inadequate government funding, political conditions or economic crises, international conflict, or natural disasters may negatively impact review, inspection, and approval timelines
9. 29A Breakthrough Therapy or Fast Track designation by the FDA may not actually lead to a faster development or regulatory review or approval process
10. 30We may seek orphan drug designation for some of our drug candidates. However, we may be unsuccessful in obtaining or may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity24% rewritten
11. 31The FDA and other comparable regulatory authorities outside of the U.S. may not accept data from trials conducted in locations outside of their respective jurisdictions33% rewritten
12. 32Approval of one of our product candidates in the United States would not assure approval of that candidate in jurisdictions outside of the U.S37% rewritten
13. 33We expect to similarly rely on contract manufacturing relationships for our development programs and any products that we may in-license or acquire in the future. However, there can be no assurance that we will be able to successfully contract with such manufacturers on terms acceptable to us, or at all
14. 34We may be unable to successfully develop, obtain regulatory approval for, or commercialize a subcutaneous formulation of our approved intravenous product, which could limit our ability to expand our market opportunity and patient reachNew

Risks Related to Governmental Regulation of Pharmaceutical Industry and Legal Compliance Matters

1. 35We are subject to new legislation, regulatory proposals and third-party payor initiatives that may increase our costs of compliance and adversely affect our ability to market our products, obtain collaborators and raise capital56% rewritten
2. 36the availability of capital23% rewritten
3. 37If we violate applicable data privacy and security laws, we may be subject to penalties, including civil and criminal penalties, damages, fines, reputation harm and the curtailment or restructuring of our operations56% rewritten
4. 38If we fail to adequately understand and comply with the local laws and customs as we expand into new international markets, these operations may incur losses or otherwise adversely affect our business and results of operations
5. 39Any product for which we obtain marketing approval, including BRIUMVI, could be subject to restrictions or withdrawal from the market and we may be subject to penalties if we fail to comply with regulatory requirements or if we experience unanticipated problems with our products
6. 40If we or any of our contract manufacturers and suppliers fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could seriously harm our business

Risks Related to Our Dependence on Third Parties

1. 41form relationships with other entities, some of which may be our competitors
2. 42the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us
3. 43Because we have in-licensed BRIUMVI and our product candidates from third parties, any dispute with or non-performance by our licensors will adversely affect our ability to develop and commercialize the applicable product or product candidate
4. 44the priority of invention of patented technology
5. 45If conflicts arise between us and our future collaborators or strategic partners, these parties may act in a manner adverse to us and could limit our ability to implement our strategies
6. 46We may seek to establish additional collaborations, and if we are not able to establish them on commercially reasonable terms, we may have to alter our development and commercialization plans

Risks Related to Our Intellectual Property

1. 47If we are not able to obtain patents that protect our product and product candidates, it could have a material adverse effect on our financial condition and results of operations
2. 48Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements
3. 49If we do not obtain patent term extensions under the Hatch-Waxman Act and similar foreign legislation extending the terms of our licensed patents and any future patents we may own, our business may be materially harmed
4. 50We may not be able to enforce our intellectual property rights throughout the world
5. 51We may be involved in lawsuits to protect or enforce our patents or the patents of our licensors, which could be expensive, time consuming and unsuccessful
6. 52If we or our partners are sued for infringing intellectual property rights of third parties, it will be costly and time consuming, and an unfavorable outcome in that litigation would have a material adverse effect on our business
7. 53We may need to license certain intellectual property from third parties, and such licenses may not be available or may not be available on commercially reasonable terms
8. 54If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed
9. 55We may be subject to damages resulting from claims that we or our employees have wrongfully used or disclosed alleged trade secrets of our competitors or are in breach of non-competition or non-solicitation agreements with our competitors

Risks Related to Our Business Organization and Governance, Strategy, Employees and Growth Management

1. 56If we fail to attract and keep key management, commercial, and clinical development personnel, we may be unable to successfully develop or commercialize our product and product candidates
2. 57We will need to develop and expand our business, and we may encounter difficulties in managing this development and expansion, which could disrupt our operations
3. 58Certain anti-takeover provisions in our governing documents and Delaware law could make a third-party acquisition of us difficult. This could limit the price investors might be willing to pay in the future for our common stock
4. 59Our ability to utilize our net operating loss (NOL) carryforwards and certain other tax attributes may be limited
5. 60Certain of our executive officers, directors, principal stockholders and their affiliates maintain the ability to exercise significant influence over our company and all matters submitted to stockholders for approval
6. 61discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us39% rewritten
7. 62Unfavorable global economic conditions and changes in government regulations could adversely affect our business, financial condition or results of operations63% rewritten
8. 63Our employees, principal investigators, CROs, CMOs and consultants may engage in misconduct or other improper activities, including non-compliance with regulatory standards and requirements and insider trading, which could have a material adverse effect on our business24% rewritten
9. 64We may acquire businesses or drugs, or form strategic alliances, in the future, and we may not realize the benefits of such acquisitions
10. 65We may be subject to adverse legislative or regulatory tax changes that could negatively impact our financial condition55% rewritten

Risks Related to Our Common Stock and Being a Publicly Traded Company

1. 66Our stock price is, and we expect it to remain, volatile, which could limit investors’ ability to sell our stock at a profit
2. 67We will not be able to control many of these factors, and we believe that period-to-period comparisons of our financial results will not necessarily be indicative of our future performance
3. 68We are subject to risks related to corporate social responsibility and reputational matters63% rewritten
4. 69Climate change or legal, regulatory or market measures to address climate change may negatively affect our business, supply chain, results of operations, financial condition and growth prospects62% rewritten
5. 70Our ability to pay dividends, if any, are limited, and our stockholders may not receive any return on investment unless they sell their common stock
6. 71An active trading market for our common stock may not be sustained, and investors may not be able to resell their shares at or above the price they paid
7. 72If equity research analysts do not publish research or reports about our business or if they publish negative evaluations of or downgrade our common stock, the price of our common stock could decline
8. 73We incur significant increased costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives53% rewritten
9. 74​Volatility in the price of our common stock may subject us to securities and shareholder derivative litigation, which could cause us to incur substantial costs and divert management’s attention, financial resources and other company assets
10. 75Future sales of our common stock, including by us or our directors and executive officers or shares issued upon the exercise of currently outstanding options, could cause our stock price to decline