VERU (VERU) risk factors, FY2024 10-K

Risks Related to the Regulation and Commercialization of Our Products and Drug Candidates

1. 01Our clinical trials may be suspended or discontinued
2. 02We could experience delays or unanticipated costs in connection with our planned clinical development program of enobosarm as a treatment to augment fat loss and to prevent lean mass (muscle) loss in sarcopenic obese or overweight patients receiving a GLP-1 RA
3. 03We may fail or elect not to commercialize our drug candidates or our approved or authorized products
4. 15We have limited experience in obtaining regulatory approval or emergency use authorization for a drug
5. 16We could experience delays in our planned clinical trials
6. 17delays resulting from shutdowns or quarantines or staffing shortages relating to a pandemic or other reasons
7. 18We could experience delays or unanticipated costs in connection with our Phase 2b clinical trial of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA
8. 19Interim, preliminary and topline data from our preclinical studies and clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data
9. 20We may be subject to risks relating to collaboration with third parties
10. 21We rely on CROs to conduct our research and development activities
11. 22We rely on third party manufacturers for our drug candidates
12. 23Disruptions to or significantly increased costs associated with transportation and other distribution channels for our products may adversely affect our margins and profitability
13. 24Changes in law could have a negative impact on the approval of our drug candidates
14. 25Our development and commercialization of sabizabulin as a treatment for ARDS will depend on our ability to secure significant funding through government grants, pharmaceutical company partnerships or similar external sources
15. 26We are subject to extensive and costly governmental regulation, including healthcare reform measures that may negatively impact sales of FC2
16. 27Any of these actions could have a material adverse effect on our business
17. 28state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including commercial insurers
18. 29We could experience misconduct by our employees
19. 30Coverage and reimbursement may not be available for our products
20. 31We may not be able to gain and retain market acceptance for our drug candidates
21. 32prevalence and severity of adverse side effects
22. 33Our drug products may be subject to governmental pricing controls
23. 34Third parties may obtain FDA regulatory exclusivity to our detriment

Risks Related to Our Financial Position and Need for Capital

1. 04We have incurred net losses in recent fiscal years and expect to continue to incur losses for the foreseeable future
2. 05Our independent registered public accounting firm has included an explanatory paragraph relating to our ability to continue as a going concern in its report on our audited financial statements included in this Annual Report on Form 10-K for the fiscal year ended September 30, 2024
3. 06The amount of additional financing that we will need to support our development and commercialization activities is uncertain
4. 35We have incurred net losses in recent fiscal years and expect to continue to incur losses for the foreseeable future
5. 36These factors could result in variations from currently projected operating and liquidity requirements
6. 37We may not receive any additional payments from ONCO in connection with the sale of our ENTADFI assets and may not receive any value for the shares of ONCO common stock that we might hold from time to time

Risks Related to Our Business

1. 07Material adverse or unforeseen legal judgments, fines, penalties, or settlements could have an adverse impact on our profits and cash flows
2. 08We 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
3. 38Our FC2 business may be affected by contracting risks with government and other international health agencies
4. 39The 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
5. 40We may experience competition, especially for enobosarm as a treatment for metabolic diseases, if approved, and FC2
6. 41Our net revenues from sales of FC2 may not return to past levels
7. 42We may not be able to successfully implement our strategy to grow sales of FC2 in the U.S. market through our own telehealth portal
8. 43An inability to identify or complete future acquisitions could adversely affect our future growth
9. 44We may experience difficulties in integrating strategic acquisitions
10. 45unanticipated management or operational problems or liabilities may adversely affect our profitability and financial condition
11. 46We may be subject to claims or investigations relating to The Pill Club’s business practices with respect to sales of FC2
12. 47It is unlikely that we will collect any amount of our accounts receivable with The Pill Club
13. 48We are subject to significant payment obligations pursuant to the resolution of a dispute with a supplier
14. 49Since we sell FC2 in foreign markets, we are subject to international business risks that could adversely affect our operating results
15. 50difficulties in our ability to enforce legal rights and remedies
16. 51Increases 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
17. 52Currency exchange rate fluctuations could increase our expenses
18. 53We rely on a single facility to manufacture FC2, and single source suppliers for certain raw materials, which subjects us to the risk of supply disruptions
19. 54We may incur costs or experience supply interruptions relating to our need to transition the supply of the nitrile polymer for FC2
20. 55Uncertainty and adverse changes in the general economic conditions may negatively affect our business
21. 56a decline in the value of our shares
22. 57We have been named a defendant in stockholder class actions. These, and potential similar or related lawsuits or investigations, could result in substantial legal fees, fines, penalties or damages and may divert management’s time and attention from our business
23. 58Our business and operations would suffer if we sustain cyber-attacks or other privacy or data security incidents that result in security breaches
24. 59Any 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
25. 60manage our development efforts effectively while carrying out our contractual obligations to partners and other third parties
26. 61Uncertainties 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
27. 62Our effective tax rate may be negatively impacted if we are unable to realize deferred tax assets or by future changes to tax laws in jurisdictions in which we operate
28. 63Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited

Risks Relating to Our Intellectual Property

1. 09We may be unable to protect the proprietary nature of the intellectual property covering our products
2. 10Our 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
3. 11We are dependent in part on some license relationships
4. 64We may be unable to protect the proprietary nature of the intellectual property covering our products
5. 65inability to control patent prosecution, maintenance, or enforcement of any in-licensed intellectual property
6. 66We may not have sufficient intellectual property protection for enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness
7. 67We 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
8. 68we may need to redesign our products so they do not infringe, which may not be possible or may require substantial monetary expenditures and time
9. 69We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of our competitors
10. 70We may need to file lawsuits or take other actions to protect or enforce our intellectual property rights
11. 71We may fail to protect the confidentiality of commercially sensitive information

Risks Related to Ownership of Our Common Stock

1. 12We have received a notice of delisting from Nasdaq
2. 13The restatements of our prior financial statements may affect stockholder and investor confidence in us or harm our reputation, and may subject us to additional risks and uncertainties, including increased costs and the increased possibility of legal proceedings and regulatory inquiries, sanctions or investigations
3. 14Because 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
4. 72Ownership in our common stock is highly concentrated and your ability to influence corporate matters may be limited as a result
5. 73a decreased ability to issue additional securities or obtain additional financing in the future
6. 74We are a “smaller reporting company” and will be able to avail ourselves of reduced disclosure requirements applicable to smaller reporting companies, which could make our common stock less attractive to investors
7. 75There are provisions in our charter documents, Wisconsin law and our residual royalty agreement that might prevent or delay a change in control of our company
8. 76The trading price of our common stock has been volatile, and investors in our common stock may experience substantial losses
9. 77A substantial number of shares may be sold in the market, which may depress the market price for our common stock