TherapeuticsMD (TXMD)

Risks

• Our financial condition and results of operations for 2020 and 2021 were, and our financial condition and results of operations for 2022 and beyond may be, adversely affected by the ongoing COVID-19 pandemic.
• We have incurred significant operating losses since inception and anticipate that we will incur continued losses for the foreseeable future.
• Our level of indebtedness and the terms of the Financing Agreement, which matures in June 2022, raises substantial doubt about our ability to continue as a going concern.
• We may not recognize any anticipated benefits of the proposed disposition of vitaCare or any other divestitures we may pursue in the future.
• We may not be able to realize the expected savings from our cost savings initiatives.
• We have experienced significant turnover in our top executives, and our business could be adversely affected by these and other transitions in our senior management team.
• We currently derive all revenue from sales or licenses of our women’s healthcare products, and our failure to maintain or increase sales of these products could have an adverse effect on our business, financial condition, results of operations, and growth prospects.
• The commercial success of our existing products and other pharmaceutical products that we may develop, if approved in the future, will depend upon gaining and retaining significant market acceptance of these products among physicians and payers.
• We may not be able to complete the commercialization of our pharmaceutical products and development of future product candidates if we fail to obtain additional financing.
• Coverage and reimbursement may not be available for our products, which could make it difficult for us to sell our products profitably, or if available, government mandated rebates may be too high and may adversely affect our profitability.
• We are subject to extensive and costly government regulation.
• Future legislation or regulations may adversely affect reimbursement from government healthcare programs and third-party payers.
• Even after the approval of IMVEXXY, BIJUVA, and ANNOVERA, and even if we obtain regulatory approval for other pharmaceutical product candidates, we will still face extensive, ongoing regulatory requirements and review, and our products may face future development and regulatory difficulties.
• Recent government enforcement has targeted pharmaceutical companies for violations of fraud, abuse and other laws.
• Licensing of intellectual property involves complex legal, business, and scientific issues, and disputes could jeopardize our rights under such agreements. Additionally, our current licensing agreements contain limitations and restrictions that could limit or adversely affect our ability to develop and commercialize other products in the future.
• Our products face significant competition from branded and generic products, and our operating results will suffer if we fail to compete effectively.
• Failure to obtain regulatory approval outside the U.S. will prevent our licensees from marketing our hormone therapy pharmaceutical products in non-U.S. markets.
• Our success is tied to our distribution channels.
• We rely on third parties to conduct our R&D activities, including our clinical trials, and we may experience delays in obtaining or may be unsuccessful in obtaining regulatory approval for, or in commercializing, our pharmaceutical product candidates if these third parties do not successfully carry out their contractual duties or meet expected deadlines.
• Our ability to utilize net operating loss carryforwards may be limited.
• Our operations are concentrated in Boca Raton, Florida and interruptions affecting us or our suppliers due to natural disasters, the COVID-19 pandemic, or other unforeseen events could adversely affect our operations.
• Any failure to adequately maintain a sales force will impede our growth.
• We will need to grow our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.
• If our efforts to protect the proprietary nature of the intellectual property covering our hormone therapy pharmaceutical products and other products are not adequate, we may not be able to compete effectively in our market.
• We may be required to file lawsuits or take other actions to protect or enforce our patents or the patents of our licensors, which could be expensive and time-consuming.
• If we fail to maintain proper internal controls, our ability to produce accurate financial statements or comply with applicable regulations could be impaired.
• We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock.
• Some provisions of our charter documents and Nevada law may have anti-takeover effects that could discourage an acquisition of us by others, even if an acquisition would be beneficial to our stockholders and may prevent attempts by our stockholders to replace or remove our current management.
• Our business may be affected by unfavorable publicity or lack of consumer acceptance.
• Our success depends on how efficiently we respond to changing consumer preferences and demand.
• We may initiate product recalls or withdrawals or may be subject to regulatory enforcement actions that could negatively affect our business.
• Product liability lawsuits could divert our resources, result in substantial liabilities, and reduce the commercial potential of our products.
• If we use hazardous materials in a manner that causes injury or violates applicable law, we may be liable for damages.
• If we are not successful in attracting and retaining highly qualified personnel, we may not be able to successfully implement our business strategy.
• A failure to maintain optimal inventory levels to meet commercial demand for our products could harm our reputation and subject us to financial losses.
• Delays in clinical trials are common for many reasons, and any such delays could result in increased costs to us and jeopardize or delay our ability to obtain regulatory approval or commence or continue product sales.
• We may be required to suspend or discontinue clinical trials because of adverse side effects or other safety risks that could preclude approval of our pharmaceutical product candidates.
• Our business may be impacted by new or changing tax laws or regulations and actions by federal, state, and/or local agencies, or how judicial authorities apply tax laws.
• We may not be able to maintain effective and efficient information systems or properly safeguard our information systems.
• Our failure to comply with foreign data protection laws and regulations could lead to government enforcement actions and significant penalties against us, and adversely impact our operating results.
• Our employees and business partners may not appropriately secure and protect confidential information in their possession.
• Another party could develop competing pharmaceutical products and obtain FDA regulatory exclusivity in the U.S. before we do, potentially preventing our ability to commercialize our pharmaceutical products and other products in development.
• If we are sued for infringing intellectual property rights of third parties, litigation will be costly and time consuming and could prevent or delay us from developing or commercializing our pharmaceutical product candidates.
• If we are unable to protect the confidentiality of certain information, the value of our products and technology could be adversely affected.
• We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers or of other third parties with whom we have obligations of confidentiality.
• The market price of our common stock may be highly volatile, and you could lose all or part of your investment.
• If securities or industry analysts do not publish research or publish inaccurate or unfavorable research about our business, our stock price and trading volume could decline.
• Future sales and issuances of equity securities, convertible securities or other securities could result in additional dilution of the percentage ownership of holders of our common stock.