Vivos Therapeutics (VVOS) risk factors, FY2024 10-K

Risks Related to Our Business and Industry

1. 01We have a history of operating losses and may never achieve cash flow positive or profitable results of operations
2. 02In summary, as of December 31, 2022 we identified material weaknesses related to the operating effectiveness of our review controls in that we did not put the appropriate resources in place to be able to identify and account for technical accounting issues and perform review functions appropriately
3. 03We expect to derive a substantial portion of our prospective future revenue from sales of our appliances and treatment pursuant to our new strategic alliance and acquisition models, which leaves us reliant on the commercial viability of The Vivos Method and other associated products and services
4. 04Our future operating results are difficult to predict and may vary significantly from quarter to quarter, which may adversely affect the price of our common stock
5. 05We may not be able to respond in a timely and cost-effective manner to changes in consumer preferences
6. 06Whenever practical, The Vivos Method is paid for primarily out-of-pocket by patients, with any available health insurance coverage being reimbursed if and as paid at a later date, where the patient is being treated for dentofacial abnormalities and/or mild to severe OSA
7. 07Our products and third-party contract manufacturing activities are subject to extensive governmental regulation that could prevent us from manufacturing or obtaining Vivos appliances or introducing new and/or improved products in the United States or internationally
8. 08Our products are currently recommended only by a relatively small minority of medical sleep specialists, who are integral to the diagnosis and treatment of sleep breathing disorders
9. 09We may not be able to protect our patents and proprietary technology and may become subject to intellectual property claims or litigation
10. 10We face the risk of product liability claims that could be expensive, divert management’s attention and harm our reputation and business
11. 11Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws
12. 12We have engaged in and will continue to pursue acquisitions of medical or dental practices or complementary businesses or technologies, which could divert the attention of management, and which may not be integrated successfully into our existing business
13. 13We could be subject to lawsuits for which we are not fully insured
14. 14We depend on certain key personnel
15. 15Members of our board of directors and our executive officers will have other business interests and obligations to other entities
16. 16We will need to carefully manage our expanding operations to achieve sustainable growth
17. 17We could be adversely affected by violations of the U.S. Foreign Corrupt Practices Act and similar worldwide anti-bribery and anti-kickback laws with respect to our activities outside the United States

Risks Related to Our Products and Regulation

1. 18We depend in large part on The Vivos Method technology, and the loss of regulatory approval or access to this technology would terminate or delay the further development of our products, injure our reputation or force us to pay higher fees
2. 19Our failure to obtain government approvals, including required FDA approvals, or to comply with ongoing, and ever increasing, governmental regulations relating to our technologies and products could delay or limit introduction of our products and result in failure to achieve revenue or maintain our ongoing business
3. 20We cannot assure that we will be able to complete any required clinical trial programs successfully within any specific time period, and if such clinical trials take longer to complete than we project, our ability to execute our current business strategy will be adversely affected
4. 21The results of our clinical trials may not support either further clinical development or the commercialization of any new product candidates or modifications to existing products
5. 22Modifications to appliances within The Vivos Method may require additional FDA approvals which, if not obtained, could force us to cease marketing and/or recall the modified device until we obtain new approvals
6. 23We are subject to regular inspection and market surveillance by the FDA to determine compliance with regulatory requirements.
7. 24Treatment with The Vivos Method has only been available for a relatively limited time, and we do not know whether there will be significant post-treatment regression or relapse
8. 25Under our alliance marketing and distribution model, our M&A Group, or formerly known as our Medical Integration Division, which will seek to acquire or create alliances with healthcare providers, may implicate federal and state laws involving the practice of medicine and related anti-kickback and similar laws

Risks Related to Our Securities Generally

1. 26The market for our common stock is relatively new and may not develop to provide investors with adequate liquidity
2. 27The market price of our common stock has been and may continue to be highly volatile, and you could lose all or part of your investment
3. 28Our failure to meet the continuing listing requirements of The Nasdaq Capital Market could result in a delisting of our securities
4. 29On July 5, 2024, we were notified that the Panel had granted our request for continued listing on Nasdaq, subject to our filing of the Form 10-Q for the quarter ended June 30, 2024, with the Securities and Exchange Commission by August 15, 2024, evidencing our compliance with the Equity Requirement
5. 30If our shares of common stock become subject to the penny stock rules, it would become more difficult to trade our shares
6. 31Actions of activist shareholders could be disruptive and potentially costly and the possibility that activist shareholders may seek changes that conflict with our strategic direction could cause uncertainty about the strategic direction of our business
7. 32We are an “emerging growth company,” and the reduced disclosure requirements applicable to emerging growth companies may make our common stock less attractive to investors
8. 33We continue to incur increased costs as a result of operating as a public company, and our management will be required to devote substantial time to new compliance initiatives
9. 34Certain provisions of our Certificate of Incorporation may make it more difficult for a third party to effect a change-of-control
10. 35Our bylaws designate certain courts as the sole and exclusive forum for certain types of actions and proceedings that may be initiated by our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees
11. 36Limitations on director and officer liability and indemnification of our officers and directors by us may discourage stockholders from bringing suit against an officer or director
12. 37We are responsible for the indemnification of our officers and directors
13. 38Our ability to use our net operating losses and research and development credit carryforwards to offset future taxable income may limited, perhaps substantially
14. 39The financial and operational projections that we may make from time to time are subject to inherent risks
15. 40If we were to dissolve, the holders of our securities may lose all or substantial amounts of their investments
16. 41An investment in our company may involve tax implications, and you are encouraged to consult your own advisors as neither we nor any related party is offering any tax assurances or guidance regarding our company or your investment
17. 42Because we do not anticipate paying any cash dividends on our capital stock in the foreseeable future, capital appreciation, if any, will be your sole source of gain
18. 43If securities or industry analysts do not publish or cease publishing research or reports about us, our business or our market, or if they change their recommendations regarding our common stock adversely, the price of our common stock and trading volume could decline