Starling Oncology (STLN) risk factors, FY2024 10-K

Risks Related to Our Business

1. 01Our growth strategy depends on our ability to build or acquire new TOI PC clinics to service our contracts and treat our patients
2. 02We have experienced, and may continue to experience, rapid growth and organizational change, which has placed, and may continue to place, significant demands on our management and our operational and financial resources
3. 03We have a history of net losses, we anticipate increasing expenses in the future, and we may not be able to achieve or maintain profitability
4. 04A pandemic, epidemic or outbreak of an infectious disease, including the re-emergence of the COVID-19 pandemic, that occurs in the United States or worldwide, may adversely affect our business
5. 05Our services are concentrated in certain geographic areas and populations exposing us to unfavorable changes in local benefit costs, reimbursement rates, competition and economic conditions
6. 06If we are unable to attract new patients, our revenue growth will be adversely affected
7. 07We primarily depend on reimbursement by third-party payors, as well as payments by individuals, which could lead to delays and uncertainties in the reimbursement process
8. 08With many of our value-based agreements, the TOI PCs assume some or all of the risk that the cost of providing services will exceed compensation. If we do not accurately predict the cost to deliver care, some of the TOI PCs’ value-based agreements could become less profitable, or unprofitable
9. 09Reductions in government reimbursement rates or changes in the rules governing government healthcare programs could have a material adverse effect on our financial condition and results of operations
10. 10We cannot predict the effect that health care reform and other changes in government programs may have on our business, financial condition or results of operations
11. 11enacted in 2010, made major changes in how healthcare is delivered and reimbursed, and it increased access to health insurance benefits to the uninsured and underinsured populations of the United States
12. 12The transition from volume to value-based reimbursement models may have a material adverse effect on our operations
13. 13Changes in the payor mix of patients and potential decreases in reimbursement rates as a result of consolidation among plans could adversely affect our revenues and results of operations
14. 14We face significant competition from other healthcare services providers. Our failure to adequately compete could adversely affect our business
15. 15Competition for physicians and nurses, shortages of qualified personnel or other factors could increase our labor costs and adversely affect our revenue, profitability and cash flows
16. 16Because competition for qualified personnel is intense, we may not be able to attract and retain the highly skilled employees we need to execute our business strategies and growth plans
17. 17Certain of our management has limited experience in operating a public company
18. 18If we are unable to provide consistently high quality of care, our business will be adversely impacted
19. 19We depend on our information technology systems, and those of our third-party vendors, contractors and consultants, and any failure or significant disruptions of these systems, security breaches or loss of data could materially adversely affect our business, financial condition and results of operations
20. 20We may be subject to legal proceedings and litigation, including intellectual property and privacy disputes, which are costly to defend and could materially harm our business and results of operations
21. 21attention of management and our affiliated providers from our core business, harm our reputation and adversely affect the TOI PCs’ ability to attract and retain patients, any of which could have a material adverse effect on our business, financial condition and results of operations
22. 22Some jurisdictions preclude the TOI PCs from entering into non-compete agreements with physicians, and other non-compete agreements and restrictive covenants applicable to certain physicians and other clinical employees may not be enforceable
23. 23Current and future acquisitions may use significant resources, may be unsuccessful, and could expose us to unforeseen liabilities
24. 24If we are unable to protect the confidentiality of our trade secrets, know-how and other proprietary and internally developed information, the value of our technology could be adversely affected
25. 25We conduct some clinical trials in contract with the TCR. If we fail to perform our clinical trial services in accordance with contractual requirements, government regulations and ethical considerations, we could be subject to significant costs or liability and our reputation could be adversely affected
26. 26Negative publicity regarding the managed healthcare industry generally could adversely affect our results of operations or business
27. 27Our managed clinics may be negatively impacted by weather and other factors beyond our control

Risks Related to Our Regulatory Environment

1. 28We are dependent on our relationships with the TOI PCs, which are affiliated professional entities that we do not own, to provide healthcare services, and our business would be harmed if those relationships were disrupted or if our arrangements with the TOI PCs become subject to legal challenges
2. 29Our managed clinics and the TOI PCs providing professional services at such clinics may become subject to medical liability claims, which could have a material adverse impact on our business
3. 30If there is a change in accounting standards by the Financial Accounting Standards Board ("FASB") or the interpretation thereof affecting consolidation of entities, it could have a material adverse effect on our consolidation of total revenues derived from the TOI PCs
4. 31Our managed clinics and the TOI PCs may be subject to third-party payor audits, which, if adversely determined against us or the TOI PCs, may have a material effect on our results of operations and financial condition
5. 32We are subject to extensive fraud, waste, and abuse laws that may give rise to federal and state audits, investigations, lawsuits and claims against us, the outcome of which may have a material adverse effect on our business, financial condition, cash flows, or results of operations
6. 33If we or the TOI PCs fail to comply with applicable data interoperability and information blocking rules, our consolidated results of operations could be adversely affected
7. 34Actual or perceived failures to comply with applicable data protection, privacy and security, advertising and consumer protection laws, regulations, standards and other requirements could adversely affect our business, financial condition and results of operations
8. 35We may not be able to utilize a portion of our NOLs to offset future taxable income for U.S. federal income tax purposes, which could adversely affect our net income and cash flows
9. 36judgment by us that may be successfully challenged by the applicable taxation authorities upon audit, which could result in additional tax liabilities

Risks Related to Our Financial Condition

1. 37Goodwill and other intangible assets represent a portion of our total assets. Goodwill is tested for impairment at least annually, which could result in a material, non-cash write-down of goodwill and could have a material adverse effect on our results of operations and stockholders’ equity
2. 38If the Company is required to record additional goodwill impairment, our financial condition and results could be negatively affected
3. 39We may need additional capital to fund our operations and finance our growth, and we may not be able to obtain it on acceptable terms, or at all, which may limit our ability to grow

Risks Related to Our Common Stock and Warrants

1. 40Our issuance of additional shares of Common Stock, Warrants or other convertible securities may dilute your ownership interest in us and could adversely affect our stock price
2. 41Future sales, or the perception of future sales, of our Common Stock and Warrants by us or our existing securityholders in the public market could cause the market price for our Common Stock and Warrants to decline
3. 42Delaware law and provisions in our Charter and Bylaws could make a takeover proposal more difficult
4. 43We are an “emerging growth company” and the reduced disclosure requirements applicable to emerging growth companies may make our Common Stock and Warrants less attractive to investors
5. 44Warrants, our ability to access the capital markets and our ability to comply with the covenants in our Facility Agreement could be negatively impacted
6. 45fail to continue to meet all applicable continued listing requirements for Nasdaq in the future, Nasdaq could delist our securities
7. 46The market price of our Common Stock may be volatile or may decline regardless of our operating performance. You may lose some or all of your investment
8. 47If securities analysts cease publishing research or reports about us, or if they issue unfavorable commentary about us or our industry or downgrade our Common Stock, the price of our Common Stock could decline
9. 48The obligations associated with being a public company involve significant expenses and require significant resources and management attention, which may divert from our business operations
10. 49incur. Our entire management team and many of our other employees have devoted and will continue to devote substantial time to compliance and may not effectively or efficiently manage our transition into a public company
11. 50We do not intend to pay dividends on our Common Stock for the foreseeable future
12. 51Our Warrants may have an adverse effect on the market price of our Common Stock

Risks Related to Our Indebtedness

1. 52The Facility Agreement and the associated restrictive covenants thereunder could adversely affect our financial condition and will restrict our ability to raise capital
2. 53The Senior Secured Convertible Note provides for certain terms which may have a negative impact on our business. Obligations under such agreement mature on August 9, 2027 and carry the possibility of the issuance of Convertible Note Warrants upon prepayment