RxSight (RXST) risk factors, FY2025 10-K

Risks related to our business and products

1. 01In order to support our continued operations and the growth of our business, we may seek to raise additional capital, which may not be available to us on acceptable terms, or at all
2. 02We face significant competition, and if we are unable to compete effectively, we may not be able to achieve or maintain significant market penetration or improve our results of operations80% rewritten
3. 08If we fail to effectively train our sales force, increase our sales and marketing capabilities or develop broad brand awareness in a cost-effective manner, our growth will be impeded, and our business will suffer28% rewritten
4. 09We have a history of net losses, and we expect to continue to incur losses in the future. If we ever achieve profitability, we may not be able to sustain it
5. 10the extent to which we acquire or invest in businesses, products or technologies
6. 11Global economic, political and market conditions, including downgrades of the U.S. credit rating, and inflation may adversely affect our business, results of operations and financial condition, including our revenue growth and profitability
7. 12Deterioration in the economic conditions globally has resulted in instability in global financial markets, including: inflation and rising interest rates and instability in the capital markets75% rewritten
8. 13Changes in U.S. trade policy, including recently announced tariffs, could have a material adverse impact on our business, financial condition, and results of operationsNew
9. 14We currently maintain all of our cash, cash equivalents and short-term investments in one financial institution and, therefore, our cash, cash equivalents and short-term investments could be adversely affected if the financial institution in which we hold our cash, cash equivalents and short-term investments fails
10. 15Our success depends in large part on our RxSight system. If we are unable to successfully market and sell our RxSight system, our business prospects will be significantly harmed, and we may be unable to achieve revenue growth22% rewritten
11. 16whether we are required by the FDA or comparable non-U.S. regulatory authorities to conduct additional clinical trials for current or future indications
12. 17Adoption of our products depends upon appropriate training for doctors, and inadequate training may lead to negative patient outcomes, affect adoption of our products and adversely affect our business28% rewritten
13. 18The commercial success of our RxSight system will depend upon attaining significant market acceptance of these products among patients and doctors
14. 19an inability to generate patient referral due to dissatisfaction with results obtained through treatment with our products, the out-of-pocket cost of treatments using our products or otherwise
15. 20Our RxSight system involves surgical risks and is contraindicated in certain patients, which may limit adoption
16. 21Product price and qualification for coverage and reimbursement
17. 22obtain, maintain, enforce and defend our intellectual property rights and operate our business without infringing, misappropriating or otherwise violating the intellectual property rights of others61% rewritten
18. 23Any collaboration or partnership arrangements that we may enter into in the future may not be successful, which could adversely affect our ability to develop and commercialize our products
19. 24If our facilities become damaged or inoperable, or if we are required to vacate a facility, we may be unable to manufacture our products or we may experience delays in production or an increase in costs, which could adversely affect our results of operations
20. 25Technological change may adversely affect sales of our products and may cause our products to become obsolete
21. 26Uncertainties with respect to the development, deployment, and use of artificial intelligence in our business and products may result in harm to our business and reputationNew
22. 27Results of earlier studies may not be predictive of future clinical trial results, and planned studies may not establish an adequate safety or efficacy profile for our RxSight system and other planned or future products, which would affect market acceptance of our RxSight system
23. 28If our clinical trials are unsuccessful or significantly delayed, or if we do not complete our clinical trials, our business may be harmed
24. 29Unauthorized third parties may seek to access our devices or other products and services, or related devices, products, and services, and modify or use them in a way inconsistent with our FDA clearances and approvals, which may create risks to users51% rewritten
25. 30We may expend our limited resources to pursue a particular product or indication and fail to capitalize on products or indications that may be more profitable or for which there is a greater likelihood of success32% rewritten
26. 31If we fail to identify, acquire and develop other products, we may be unable to grow our business
27. 32We may acquire other companies or technologies, which could fail to result in a commercial product or increased revenue, divert our management’s attention, result in additional dilution to our stockholders and otherwise disrupt our operations and harm our operating results
28. 33Coverage and adequate reimbursement and/or the ability of patients to pay for the difference between the price charged by practices and the reimbursement amount may not be available for our products in sufficient markets, which could diminish our sales or affect our ability to sell our products
29. 34the inability to market and sell our products
30. 35These and other risks associated with international operations may materially adversely affect our ability to attain or maintain profitable operations in international markets, which would have a material adverse effect on our business, financial condition and results of operations
31. 36We may not be able to achieve or maintain satisfactory pricing and margins for our products
32. 37The sizes of the markets for our current and future products have not been established with precision and may be smaller than we estimate
33. 38Our quarterly and annual results may fluctuate significantly and may not fully reflect the underlying performance of our business
34. 39We have expanded, and may continue to expand, our organization, including expanding our sales and marketing capability and creating additional infrastructure to support our operations as a public company, and as a result, we may encounter difficulties in managing our growth, which could disrupt our operations
35. 40Certain of our operating results and financial metrics may be difficult to predict as a result of seasonality43% rewritten
36. 41Our ability to use our net operating loss carryforwards and certain other tax attributes to offset future taxable income may be subject to certain limitations23% rewritten

Risks related to intellectual property

1. 03We may not be able to protect our intellectual property rights throughout the world, which could impair our business
2. 42If we are unable to obtain, maintain, protect and enforce patent and other intellectual property protection for our technology and products, or if the scope of the patent and other intellectual property protection obtained is not sufficiently broad, we may not be able to compete effectively in our markets94% rewritten
3. 43lose our technological or competitive advantage, or we may incur substantial litigation costs in our attempts to recover or restrict use of our intellectual propertyNew
4. 44Patent terms may be inadequate to protect our competitive position on technology for an adequate amount of time
5. 45Obtaining 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 noncompliance with these requirements
6. 46We may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect our ability to develop and market our products
7. 47Our future reliance on third parties may require us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed82% rewritten
8. 48use or disclosure would impair our competitive position and may have an adverse effect on our business and results of operationsNew
9. 49We may become a party to intellectual property litigation or administrative proceedings that could be costly and could interfere with our ability to sell and market our products58% rewritten
10. 50Because of the expense and uncertainty of litigation, we may not be in a position to enforce our intellectual property rights against third parties
11. 51Our rights to develop and commercialize our products are subject, in part, to the terms and conditions of licenses granted to us by others
12. 52Our potential licensors may have relied on third-party consultants or collaborators or on funds from third parties such that our licensors are not the sole and exclusive owners of the patents we in-license. This could materially and adversely affect our business, financial condition and results of operations
13. 53If disputes over intellectual property that we license in the future prevent or impair our ability to maintain our licensing arrangements on acceptable terms, we may not be able to successfully develop and commercialize the affected products, which would have a material adverse effect on our business24% rewritten
14. 54We may not be successful in obtaining necessary rights to any products we may develop through acquisitions and in-licenses
15. 55We may be subject to claims challenging the inventorship of our patents and other intellectual property
16. 56If we are unable to protect the confidentiality of our trade secrets and other proprietary information, our business and competitive position may be harmed
17. 57Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing our ability to protect our products45% rewritten
18. 58Intellectual property rights do not necessarily address all potential threats to our competitive advantage
19. 59Our use of “open source” software could subject our proprietary software to general release, adversely affect our ability to sell our products and subject us to possible litigation
20. 60If our trademarks, service marks and tradenames are not adequately protected, then we may not be able to build name recognition in our markets and our business may be adversely affected

Risks related to government regulation

1. 04If we fail to obtain and maintain necessary regulatory clearances or approvals for our products, or if clearances or approvals for future products and indications are delayed or not issued, our commercial operations may be harmed
2. 61If we fail to obtain and maintain necessary regulatory clearances or approvals for our products, or if clearances or approvals for future products and indications are delayed or not issued, our commercial operations would be harmed22% rewritten
3. 62Before a new medical device, or a new intended use for an existing product, can be marketed in the U.S., a company must first submit and receive either 510(k) clearance pursuant to Section 510(k) of the FDCA, or approval of a premarket approval, or PMA, application from the FDA, unless an exemption applies54% rewritten
4. 63longer, from the time the PMA is submitted to the FDA until an approval is obtained. Any delay or failure to obtain necessary regulatory approvals or clearances would have a material adverse effect on our business, financial condition and results of operationsNew
5. 64the FDA or foreign regulatory authorities may audit our clinical trial data and conclude that the data is not sufficiently reliable to support approval or clearance
6. 65Our products and operations are subject to extensive government regulation and oversight in the U.S48% rewritten
7. 66that our promotional materials or training constitute promotion of an off-label or other improper use, or that our internal policies and procedures are inadequate to prevent such off-label uses, it could subject us to regulatory or enforcement actions as discussed belowNew
8. 67In addition, violations of the FDCA relating to the promotion of approved products may lead to investigations alleging violations of federal and state healthcare fraud and abuse and other laws, as well as state consumer protection laws
9. 68challenges brought against the FDA, or the nature or extent of government regulation that may arise from future legislation or administrative actionNew
10. 69Material modifications to our products may require new 510(k) clearances or pre-market approvals or may require us to recall or cease marketing our products until clearances or approvals are obtained
11. 70Our products may be subject to recalls after receiving FDA or foreign approval or clearance, which could divert managerial and financial resources, harm our reputation and adversely affect our business50% rewritten
12. 71If we, or our suppliers, fail to comply with the FDA’s QMSR or other applicable foreign regulations, our manufacturing or distribution operations could be delayed or shut down and our revenue could suffer30% rewritten
13. 72Healthcare reform initiatives and other administrative and legislative proposals may adversely affect our business, financial condition, results of operations and cash flows in our key markets79% rewritten
14. 73the availability of capital
15. 74If we fail to comply with U.S. federal and state fraud and abuse and other healthcare laws and regulations, we could face substantial penalties and our business operations and financial condition could be adversely affected
16. 75Changes in the CMS fee schedules may harm our revenue and operating results
17. 76Legislative or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearance or approval of our planned or future products and to manufacture, market and distribute our products after clearance or approval is obtained
18. 77Compliance with the EU Medical Device Regulation, applicable regulations in the United Kingdom, and other applicable foreign regulations, as well as any changes to existing regulations, may be costly and disruptive to our business, and expose us to increased liability
19. 78more power to notified bodies
20. 79Our clinical trials may fail to demonstrate competent and reliable evidence of the safety and effectiveness of our products, which would prevent or delay commercialization of our products in development
21. 80Defects or failures associated with our products could lead to recalls, safety alerts or litigation, as well as significant costs and negative publicity34% rewritten
22. 81eventual outcome, could be costly, could divert management’s attention from our business and might result in adverse publicity, which could result in reduced acceptance of our products in the market, product recalls or market withdrawalsNew
23. 82Our employees, independent contractors, consultants, commercial partners, distributors and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements
24. 83Environmental health and safety laws may result in liabilities, expenses and restrictions on our operations. Failure to comply with environmental laws and regulations could subject us to significant liability
25. 84We face risks related to our collection and use of data, which could result in investigations, inquiries, litigation, fines, legislative and regulatory action and negative press about our privacy and data and security protection practices70% rewritten
26. 85Our global operations can expose us to numerous and sometimes conflicting legal and regulatory requirements, including to anti-bribery and anti-corruption laws, such as the FCPA and the U.K. Bribery Act, and violation of these requirements could result in substantial penalties and prosecution and harm our business27% rewritten

Risks related to reliance on third parties

1. 05We depend upon third parties, including single and sole source suppliers, to manufacture certain components and subcomponents of the RxSight system, making us vulnerable to supply disruptions and price fluctuations100% rewritten
2. 86From time to time, we engage outside parties to perform services related to certain of our clinical studies and clinical trials. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may not be able to obtain regulatory approval for or commercialize our products
3. 87We and our component suppliers may not meet regulatory quality standards applicable to our manufacturing processes, which could have an adverse effect on our business, financial condition and results of operations
4. 88We depend upon third parties, including single and sole source suppliers, to manufacture certain components and subcomponents of the RxSight system making us vulnerable to supply disruptions and price fluctuations100% rewritten
5. 89The failure of third parties to meet their contractual, regulatory, and other obligations could adversely affect our business36% rewritten

Risks related to our common stock

1. 06The price of our stock may be volatile, and you could lose all or part of your investment99% rewritten
2. 07We must recruit, retain, manage and motivate qualified executives as we build out the management team, and we are highly dependent on our management teamNew
3. 90The price of our stock has been and may continue to be volatile, and you could lose all or part of your investment100% rewritten
4. 91The realization of any of the above risks or any of a broad range of other risks, including those described in this Part I, Item1A, “Risk Factors,” could have a dramatic and adverse impact on the market price of our common stock49% rewritten
5. 92If securities or industry analysts do not publish research or publish unfavorable research about our business, our stock price and trading volume could decline
6. 93As of December 31, 2025, we had 41,242,005 shares of common stock issued and outstanding. All of these shares are available for sale in the public market, subject to limitations under Rule 144 with respect to affiliates of our company41% rewritten
7. 94If we fail to maintain proper and effective internal controls, our ability to produce accurate financial statements on a timely basis could be impaired
8. 95We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock
9. 96Provisions in our certificate of incorporation, bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our common stock
10. 97require a super-majority vote of stockholders to amend some provisions described above
11. 98any action asserting a claim against us that is governed by the internal-affairs doctrine
12. 99Taxing authorities may successfully assert that we should have collected or in the future should collect sales and use, value added or similar taxes, and we could be subject to liability with respect to past or future sales, which could adversely affect our results of operations
13. 100Our Board of Directors are authorized to issue and designate shares of our preferred stock in additional series without stockholder approval under our charter documents and Delaware law
14. 101Changes in tax laws or regulations that are applied adversely to us or our customers may have a material adverse effect on our business, cash flow, financial condition or results of operations48% rewritten
15. 102Our success is highly dependent on our ability to attract and retain highly skilled executive officers and employees
16. 103Our business and operations would suffer in the event of system failures or security breaches or incidents
17. 104Economic conditions may adversely affect our business76% rewritten
18. 105Litigation and other legal proceedings may adversely affect our business58% rewritten
19. 106Business disruptions could seriously harm our future revenue and financial condition and increase our costs and expenses
20. 107Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our products and manage our inventory