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Risks

• Risks Related to the Regulation and Commercialization of Our Products and Drug Candidates
• We have no experience in obtaining regulatory approval for a drug.
• We could experience delays in our planned clinical trials.
• Our clinical trials may be suspended or discontinued.
• We may be subject to risks relating to collaboration with third parties.
• We intend to rely on CROs to conduct our research and development activities.
• We expect to rely on third party manufacturers for our drug candidates.
• Changes in law could have a negative impact on the approval of our drug candidates.
• We may fail or elect not to commercialize our drug candidates.
• We are subject to extensive and costly governmental regulation, including healthcare reform measures that may negatively impact sales of FC2.
• We could experience misconduct by our employees.
• Coverage and reimbursement may not be available for our products.
• We may not be able to gain and retain market acceptance for our drug candidates.
• Our drug products may be subject to governmental pricing controls.
• Third parties may obtain FDA regulatory exclusivity to our detriment.
• Risks Related to Our Financial Position and Need for Capital
• Additional financing will be needed to support our development activities.
• COVID-19 and its impact on the economic environment and capital markets could adversely affect our access to capital when needed.
• If we fail to obtain additional capital, we may need to reduce the scope of our development programs or we could be forced to share our rights to technologies with third parties on terms that may not be favorable to us.
• Our application for our PPP Loan could in the future be determined to have been impermissible or could result in damage to our reputation.
• Risks Related to Our Business
• The COVID-19 pandemic has disrupted, and may continue to disrupt, our operations and the operations of our suppliers and customers.
• Our FC2 business may be affected by contracting risks with government and other international health agencies.
• The FDA issued a final order reclassifying female condoms as Class II medical devices, which may result in increased competition for FC2 in the U.S. market.
• We may experience intense competition.
• We may not be able to successfully implement our strategy to grow sales of FC2 in the U.S. market.
• We may not be able to sustain price levels for sales of FC2 in the U.S. market.
• An inability to identify or complete future acquisitions could adversely affect our future growth.
• We may experience difficulties in integrating strategic acquisitions.
• Disruptions from an exit of the United Kingdom from the European Union could adversely affect our business and results of operations.
• Increases in the cost of raw materials, labor, and other costs used to manufacture FC2 could increase our cost of sales and reduce our gross margins.
• Currency exchange rate fluctuations could increase our expenses.
• We rely on a single facility to manufacture FC2, which subjects us to the risk of supply disruptions.
• Uncertainty and adverse changes in the general economic conditions may negatively affect our business.
• Material adverse or unforeseen legal judgments, fines, penalties, or settlements could have an adverse impact on our profits and cash flows.
• Any failure to comply with the FCPA and similar anti-bribery laws in non-U.S. jurisdiction could materially adversely affect our business and result in civil and/or criminal sanctions.
• We will need to increase the size and complexity of our organization in the future, and we may experience difficulties in executing our growth strategy and managing any growth.
• Our credit agreement contains debt covenants which restrict our current and future operations, including our ability to take certain actions.
• Uncertainties in the interpretation and application of tax rules in the various jurisdictions in which we operate could materially affect our deferred tax assets, tax obligations and effective tax rate.
• Risks Relating to Our Intellectual Property
• We may be unable to protect the proprietary nature of the intellectual property covering our products.
• Our or our licensors’ patents may expire or be invalidated, found to be unenforceable, narrowed or otherwise limited or our or our licensors’ patent applications may not result in issued patents or may result in patents with narrow, overbroad, or unenforceable claims.
• We are dependent in part on some license relationships.
• We may face claims that our intellectual property infringes on the intellectual property rights of third parties. If we infringe intellectual property rights of third parties, it may increase our costs or prevent us from being able to commercialize our product candidates.
• We must submit patent certifications in connection with the 505(b)(2) FDA regulatory pathway.
• We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of our competitors.
• We may need to file lawsuits or take other actions to protect or enforce our intellectual property rights.
• We may fail to protect the confidentiality of commercially sensitive information.
• Risks Related to Ownership of Our Common Stock
• Ownership in our common stock is highly concentrated and your ability to influence corporate matters may be limited as a result.
• We incurred a charge to earnings in fiscal 2020 resulting from the APP Acquisition, and additional charges to earnings resulting from the APP Acquisition in the future may cause our operating results to suffer.
• If we fail to maintain effective internal control over financial reporting, our ability to produce accurate financial statements or comply with applicable regulations could be impaired.
• The trading price of our common stock has been volatile, and investors in our common stock may experience substantial losses.
• If our stock price declines, our common stock may be subject to delisting from the NASDAQ Capital Market.
• A substantial number of shares may be sold in the market, which may depress the market price for our common stock.
• Because we do not anticipate paying any cash dividends on our common stock in the foreseeable future, capital appreciation, if any, will be our shareholders’ sole source of gain.