TG Therapeutics (TGTX) risk factors, FY2024 10-K

Risks Related to Commercialization

1. 01If we obtain U.S. Food and Drug Administration (FDA) or European Medicines Agency (EMA) approval for a product candidate and do not achieve broad market acceptance among physicians, patients, healthcare payors, and the medical community, the revenues that we generate from product sales will be limited
2. 02favorable or unfavorable publicity relating to our products or relating to the Company
3. 03We may be subject to limitations on the indicated uses or requirements to fulfill certain post-marketing requirements 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
4. 04BRIUMVI, and any of our product candidates for which we in the future obtain approval, may, after approval, be found to cause undesirable side effects that could result in significant negative consequences following commercialization
5. 05our reputation may suffer
6. 06We 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
7. 07The 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
8. 08BRIUMVI, 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 business
9. 09Commercialization 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
10. 10unforeseen costs and expenses associated with creating a commercialization organization
11. 11Product liability lawsuits against us could cause us to incur substantial liabilities and could limit commercialization of any drug candidates that we may develop
12. 12the inability to commercialize any products or product candidates that we may develop
13. 13Any contracts that we enter into with government entities may involve future funding and compliance risks

Risks Related to Our Financial Position and Need for Additional Capital

1. 14We have incurred significant operating losses since our inception, and we may incur losses in the future
2. 15While 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 efforts
3. 16the extent to which we in-license or invest in other indications or product candidates
4. 17Raising 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 resources
5. 18Due 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 success
6. 19Our 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. 20We may not have cash available in an amount sufficient to enable us to make interest or principal payments on our indebtedness when due
8. 21Our 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. 22If we are unable to maintain or obtain regulatory approval for our product and 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. 23If 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. 24Clinical 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. 25have the drug removed from the market after obtaining marketing approval
5. 26Biologics carry unique risks and uncertainties, which could have a negative impact on our business
6. 27Our product or product candidates may cause undesirable side effects that could delay or prevent their regulatory approval or impact their availability and commercial potential after approval
7. 28Any 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 approvals
8. 29facilities of third-party manufacturers with which we or our collaborators currently contract for clinical supplies and
9. 30interruptions or delays in the operations of the FDA and foreign regulatory authorities 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
10. 31We are currently focusing the majority of our efforts on maintaining approval, improving and commercializing BRIUMVI and developing azer-cel for particular indications. As a result, we may fail to capitalize on other indications or product candidates that may ultimately have proven to be more profitable
11. 32A Breakthrough Therapy or Fast Track designation by the FDA may not actually lead to a faster development or regulatory review or approval process
12. 33We 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 exclusivity
13. 34The FDA, EMA and other comparable foreign regulatory authorities may not accept data from trials conducted in locations outside of their respective jurisdictions
14. 35Approval of one of our product candidates in the United States would not assure approval of that candidate in foreign jurisdictions
15. 36We 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

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

1. 37We 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 capital
2. 38the availability of capital
3. 39If 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 operations
4. 40If 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. 41Any 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 products
6. 42If 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. 43form relationships with other entities, some of which may be our competitors
2. 44the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us
3. 45Because 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. 46the priority of invention of patented technology
5. 47If 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. 48We 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. 49If 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. 50Obtaining 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. 51If 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. 52We may not be able to enforce our intellectual property rights throughout the world
5. 53We 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. 54If 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. 55We 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. 56If we are unable to protect the confidentiality of our trade secrets, our business and competitive position may be harmed
9. 57We 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. 58If 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. 59We 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. 60Certain 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. 61Our ability to utilize our net operating loss carryforwards and certain other tax attributes may be limited
5. 62Certain 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. 63discouraging a potential acquirer from making a tender offer or otherwise attempting to obtain control of us
7. 64Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations
8. 65Our 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 business
9. 66We may acquire businesses or drugs, or form strategic alliances, in the future, and we may not realize the benefits of such acquisitions
10. 67We may be subject to adverse legislative or regulatory tax changes that could negatively impact our financial condition

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

1. 68Our stock price is, and we expect it to remain, volatile, which could limit investors’ ability to sell our stock at a profit
2. 69We 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. 70We are subject to risks related to corporate social responsibility and reputational matters
4. 71Climate 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 prospects
5. 72Our 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. 73An 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. 74If 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. 75We incur significant increased costs as a result of operating as a public company, and our management is required to devote substantial time to compliance initiatives
9. 76​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. 77Future 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