Vicarious Surgical (RBOT) risk factors, FY2024 10-K

Risks Related to Our Financial Condition and Capital Requirements

1. 01There is substantial doubt about whether the Company can continue as a going concern
2. 02We have incurred significant losses since inception. As such, you cannot rely upon our historical operating performance to make an investment or voting decision regarding us

Risks Related to Our Business and Operations

1. 03We are a development stage company with a limited history of operations and no products with marketing authorization in any jurisdiction, and we cannot assure you that we will ever have a commercialized product
2. 04If we do not successfully manage the development and launch of the Vicarious Surgical System, our business, operating and financial results and condition could be adversely affected
3. 05The market for the Vicarious Surgical System and the use of robotic-assisted surgical technology is rapidly evolving, and increasingly competitive, as the healthcare industry is undergoing significant structural change, which makes it difficult to forecast demand for our product candidates and technologies
4. 06Because our markets are highly competitive, customers may choose to purchase our competitors’ products or services or may not accept the Vicarious Surgical System for use in ventral hernia repair procedures, which would result in a reduced ability to generate future revenue
5. 07Surgeons, hospitals, ASCs and distributors may have existing relationships with other medical device companies that make it difficult for us to establish new relationships with them, and as a result, we may not be able to sell and market the Vicarious Surgical System effectively
6. 08Any failure in our efforts to train surgeons, hospital or ASC staff could result in lower than expected product sales and potential liabilities
7. 09Robotic-assisted surgical device development is costly and involves continual technological change, which may render the Vicarious Surgical System obsolete
8. 10We will need to expand our organization, and we may experience difficulties in recruiting needed additional employees and consultants, which could disrupt our operations
9. 11We have no experience in marketing and selling the Vicarious Surgical System and if we are unable to successfully commercialize the Vicarious Surgical System, our business and operating results will be adversely affected
10. 12If we experience decreasing prices for our product candidates and technologies and are unable to reduce our expenses, including the per unit cost of producing our product candidates and technologies, there may be a material adverse effect on our business, results of operations, financial condition and cash flows
11. 13We may experience manufacturing problems or delays that could limit the growth of our revenue or increase our losses
12. 14Acquisitions, joint ventures or strategic alliances could disrupt our business, cause dilution to our stockholders and otherwise harm our business
13. 15Foreign acquisitions involve unique risks in addition to those mentioned above, including those related to the integration of operations across different cultures and languages, currency risks and the particular economic, political and regulatory risks associated with specific countries
14. 16If we do not successfully develop, optimize and operate our sales and distribution channels or we do not effectively expand and update infrastructure, our operating results and customer experience may be negatively impacted
15. 17If we are unable to continue the development of an adequate sales and marketing organization and/or if our direct sales organization is not successful, we may have difficulty achieving market awareness and selling our product and technologies in the future
16. 18If we are unable to establish and maintain adequate sales and marketing capabilities or enter into and maintain arrangements with third parties to sell and market the Vicarious Surgical System, our business may be harmed
17. 19Quality problems could lead to recalls or safety alerts and/or reputational harm and could have a material adverse effect on our business, results of operations, financial condition and cash flows
18. 20Unfavorable global economic conditions could adversely affect our business, financial condition or results of operations
19. 21Geopolitical conflicts could potentially affect our sales and disrupt our operations and could have a material adverse impact on us
20. 22The requirements of being a public company may strain our resources and divert management’s attention, which could adversely affect our business, results of operations, and financial condition
21. 23Our failure to maintain compliance with the NYSE’s continued listing requirements could result in the delisting of our Class A common stock
22. 24Our ability to use net operating losses to offset future income may be subject to certain limitations
23. 25Changes in our effective tax rate or disallowance of our tax positions may adversely affect our financial position and results of operations
24. 26We could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act and other worldwide anti-bribery laws by us or our agents

Risks Related to Healthcare Industry Shifts and Changing Regulations

1. 27We are subject to extensive government regulation, which could restrict the development, marketing, sale and distribution of our product candidates and technologies and could cause us to incur significant costs
2. 28To ensure compliance with regulatory requirements, medical device manufacturers are subject to post-market surveillance and periodic, pre-scheduled and unannounced inspections by the FDA or other regulatory authorities, and these inspections may include the manufacturing facilities of our subcontractors
3. 29The occurrence of any of these events may have a material adverse effect on our business, financial condition and results of operations
4. 30Unsuccessful animal studies, clinical trials or procedures relating to product candidates and technologies under development could have a material adverse effect on our prospects
5. 31Attracting patients to perform clinical trials and meeting clinical trial objectives can be more costly and time-consuming than expected and could be adversely affected by another health crisis
6. 32If allowed to proceed with our clinical development programs, we intend to conduct clinical trials for certain of our product candidates at sites outside of the United States, and the U.S. regulatory agencies may not accept data from trials conducted in such locations
7. 33In addition, changes in the FDA’s marketing authorization pathways for medical devices could make authorization more difficult to obtain, increase delay, add uncertainty and have other significant adverse effects on our ability to obtain and maintain authorization for our product candidates
8. 34If we fail to obtain regulatory authorizations in other countries for existing or future product candidates, we will not be able to commercialize these product candidates and technologies in those countries
9. 35We may be subject to enforcement action if we engage in improper or off-label marketing or promotion of the Vicarious Surgical System, including fines, penalties and injunctions
10. 36Our employees, independent contractors, principal investigators, contract research organizations, consultants or vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
11. 37Health-care policy and payment changes may have a material adverse effect on our financial condition and results of operations

Risks Related to Our Intellectual Property

1. 38If we are unable to protect our intellectual property, our ability to maintain any technological or competitive advantage over our competitors and potential competitors would be adversely impacted, and our business may be harmed
2. 39The measures that we use to protect the security of our intellectual property and other proprietary rights may not be adequate, which could result in the loss of legal protection for, and thereby diminish the value of, such intellectual property and other rights
3. 40We may need or may choose to obtain licenses from third parties to advance our research or allow commercialization of our current or future product candidates and technologies, and we cannot provide any assurances that we would be able to obtain such licenses
4. 41If disputes over licensed intellectual property prevent or impair our ability to maintain the licensing arrangements on acceptable terms, we may be unable to successfully develop and commercialize the affected product, or the dispute may have an adverse effect on our results of operations
5. 42We and our partners may be sued for infringing the intellectual property rights of third parties. If that happens, such litigation would be costly and time consuming, and an unfavorable outcome in any such litigation could have a material adverse effect on our business
6. 43We 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
7. 44Our issued patents could be found invalid or unenforceable if challenged in court, which could have a material adverse effect on our business
8. 45We may be subject to claims that our employees, consultants or independent contractors have wrongfully used or disclosed alleged trade secrets of their other clients or former employers to us, which could subject us to costly litigation
9. 46We may be subject to claims challenging the inventorship or ownership of our patents and other intellectual property
10. 47We may not be able to protect our intellectual property rights throughout the world, which could materially, negatively affect our business
11. 48Patent terms may be inadequate to protect our competitive position on technology for an adequate amount of time
12. 49Obtaining and maintaining our 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
13. 50If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected
14. 51Numerous factors may limit any potential competitive advantage provided by our intellectual property rights
15. 52We face the risk of product liability claims and may be subject to damages, fines, penalties and injunctions, among other things
16. 53We may face litigation and other risks as a result of the material weakness in our internal controls over financial reporting

Risks Related to Our Securities and to Being a Public Company

1. 54Our outstanding warrants increase the number of shares eligible for future resale in the public market and, if exercised, will result in significant dilution to our stockholders
2. 55The valuation of our warrants could increase the volatility in our net income (loss) in our consolidated statements of operations
3. 56We cannot predict the impact our dual class structure may have on the stock price of our Class A common stock
4. 57If securities or industry analysts do not publish research or reports about our business or if they issue an adverse or misleading opinion regarding our securities, our stock price and trading volume could decline
5. 58Delaware law and our organizational documents contain certain provisions, including anti-takeover provisions that limit the ability of stockholders to take certain actions and could delay or discourage takeover attempts that stockholders may consider favorable
6. 59Changes in laws or regulations, or a failure to comply with any laws and regulations, or any litigation that we may be subject to or involved in may adversely affect our business, investments and results of operations
7. 60Although we are not a “controlled company” within the meaning of the NYSE rules, we might become a “controlled company” in the future, and, as a result, our stockholders may not have certain corporate governance protections that are available to stockholders of companies that are not controlled companies
8. 61Our principal stockholders and management will exert significant influence over us and their interests may conflict with yours in the future